Clinical Research
This is a listing of Loyola University Health System clinical research that is open and actively recruiting patients. Please click on the name of the research for a brief description, eligibility requirements and contact information. All research listed below have been approved by Loyola's Institutional Review Board chairman for promotion on our Web site.
For more information call (888) LUHS-888.
Cancer
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients with Hematologic Malignancies and Other Indications
The primary aim of this multicenter study is to examine the incidence of neutrophil recovery of =500/mm3 after cord blood transplantation using CBUs that are not licensed by the Food and Drug Administration (FDA).
A Phase III, Randomized, Placebo-controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy
The purpose of the study is to assess the safety and tolerability of V212 when administered to adults with solid tumor malignancy or hematologic malignancy and to assess the impact of V212 on the development of herpes zoster.
An Exploratory Phase 1/2 Trial Evaluating ALD518 as a First
Line Therapy for Participants with Glucocorticoid-Refractory
Acute Graft vs. Host Disease (GVHD) after Allogeneic
Hematopoetic Stem Cell Transplant (HSCT) and as a First
Line Therapy for Participants with Grade 2-4 Acute GVHD in
Combination with Steroids vs. Steroids Alone
Trial will determine safe, tolerable, biologically active and potentially effective dose(s) of ALD518 in participants with acute GVHD, who have failed to respond to glucocorticosteroids.
An Open Label, Double Arm, Single Center Pilot Study to Evaluate the Safety and Efficacy of Transplantation of either StemEx®, Umbilical Cord Blood (UCB) Stem and Progenitor cells Expanded Ex vivo, or an Unmanipulated Cord Blood Unit in the Elderly Population with Hematologic Malignancies using a Reduced Intensity Regimen.
To assess the safety of StemEx® vs unmanipulated UCB transplantation following RIC regimen in the elderly population on overall 100 day survival. To assess the efficacy of StemEx® vs. unmanipulated UCB transplantation following RIC regimen in the elderly population on full donor chimerism at Day 100.
Phase 2 Study of Oral Ezatiostat Hydrochloride in Patients with Lenalidomide Refractory or Resistant, Low to Intermediate-1 Risk, Deletion 5q Myelodysplastic Syndrome (TLK199.2107)
This is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat HCl in patients with lenalidomide refractory or resistant, RBC transfusion dependent, Low to INT-1 IPSS risk, del(5q) MDS. The HI-E, RBC TI, HI-N, HI-P, and cytogenetic response rates will be evaluated by the International Working Group (IWG) 2006 MDS response criteria. Patients will receive a starting dose of 2000 mg total daily in divided doses (1000 mg orally [PO] twice daily [b.i.d.]) for three weeks (21 days) on therapy followed by a one-week off-therapy rest period in four-week treatment cycles. Patients will continue treatment until documentation of lack of MDS response, MDS progression, unacceptable toxicity, or patient withdrawal from the study.
RTOG 0834/EORTC 26053_22054/NCIC CTG CEC.1
Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1P/19Q-deleted Anaplastic Glioma: The CATNON Intergroup Trial.
The purpose of this study is to determine whether the addition of temozolomide treatment to radiotherapy (concomitant treatment) or the addition of temozolomide treatment after completion of radiotherapy on five days out of every 28 days for 12 months (adjuvant treatment) will improve the results of the treatment. This study will find out what effects, good and/or bad, the addition of temozolomide has when it is given at the same time as radiotherapy, after radiotherapy or both.
Cancer: Bladder
A Phase III Surgical Trial to Evaluate the Benefit of a Standard versus an Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle-Invasive Urothelial Cancer.
To compare disease-free survival (DFS) in participants undergoing radical cystectomy for muscle-invasive urothelial carcinoma of the bladder (UCB) treated with radical cystectomy and extended pelvic lymph node dissection (PLND) compared to radical cystectomy and standard pelvic lymphadenectomy.
Open Vs. Robotic-assisted Radical Cystectomy: A Randomized Trial, Protocol Number 36911
The primary objective of this study is to compare progression-free survival of RARC versus ORC in participants with bladder cancer. More specifically, the primary endpoint for this study is progression-free survival at two years.
Cancer: Bladder and Urinary
A Randomized, Double-blinded Phase III Study Comparing Gemcitabine, Cisplatin and Bevacizumab to Gemcitabine, Cisplatin and Placebo in Patients With Advanced Transitional Cell Carcinoma of the Urinary Tract
The purpose of this study is to determine if patients with advanced transitional cell carcinoma treated with bevacizumab, gemcitabine and cisplatin will have increased overall survival when compared to patients treated with gemcitabine, cisplatin and placebo.
Cancer: Bone
A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment
The primary objective of this study is to prospectively assess the cumulative incidence of osteonecrosis of the jaw (ONJ) at three years in cancer participants with bone metastasis receiving zoledronic acid treatment.
Cancer: Breast
(APHINITY BIG 4-11/BO25126/TOC4939G) A Randomized Multicenter, Double-blind, Placebo-controlled Comparison of Chemotherapy plus Trastuzumab plus Placebo Versus Chemotherapy plus Trastuzumab plus Pertuzumab as Adjuvant Therapy in Participants with Operable HER2-positive Primary Breast Cancer.
This trial will compare invasive disease-free survival (IDFS) in patients with HER2-positive breast cancer randomized to chemotherapy plus one year of trastuzumab plus placebo or chemotherapy plus one year of trastuzumab plus pertuzumab.
A Phase IIB Randomized Controlled Biomarker Modulation Study of
Vitamin D in Premenopausal Women at High Risk for Breast Cancer
This study will assess whether mammographic density is reduced in premenopausal women at high risk of breast cancer taking high-dose vitamin D3 (cholecalciferol 20,000 IU PO weekly) compared with high-risk women taking placebo for one year.
A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy and Radiation Therapy Alone for Women With HER2-positive Ductal Carcinoma In Situ Resected by Lumpectomy
The purpose of this study is to determine the value of trastuzumab given during radiation therapy compared to radiation therapy alone in preventing the subsequent occurrence of ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence or ipsilateral ductal carcinoma in situ (DCIS) in women with HER2-positive DCIS resected by lumpectomy.
A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival In Early Stage Breast Cancer
The purpose of this study is to compare invasive disease-free survival (IDFS) between subjects treated with metformin (850 mg po bid for five years) versus placebo in addition to standard adjuvant therapy.
A Phase III Randomized, Multicenter, Two-arm, Open-label Trial to Evaluate the Efficacy of T-DM1Compared With Treatment of Physician’s Choice in Patients with HER2-Positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy
The purposes of this study are to evaluate the efficacy of T-DM1 compared with treatment of physician’s choice in patients with HER2-positive MBC who have progression after at least two regimens of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting, as measured by the following: ORR based on independent review of tumor assessment using RECIST v. 1.1 or overall survival (OS).
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with One to Three Positive Nodes, Hormone Receptor-positive and HER2-negative Breast Cancer with Recurrence Score (RS) of 25 or Less
The purpose of this study is to determine the effect of chemotherapy in patients with node-positive breast cancer who do not have high recurrence scores (RS). In patients with one to three positive nodes, hormone receptor-positive and HER2-negative breast cancer with RS = 25 treated with endocrine therapy, we will test whether the difference in disease-free survival for patients treated with chemotherapy compared to no chemotherapy depends directly upon the magnitude of RS. If benefit depends on the RS score, the trial will determine the optimal cutpoint for recommending chemotherapy or not.
A Randomized Phase II Trial of Weekly Nanoparticle Albumin-Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A) and Cyclophosphamide (C) Plus Pegfilgrastim (PEG-G) As Neoadjuvant Therapy for Inflammatory and Locally Advanced Her-2/Neu Negative Breast Cancer
The purposes of this study are to compare the pathologic complete response (pCR) rates in patients randomized to bevacizumab versus no bevacizumab, to compare the overall survival of patients randomized to the bevacizumab arm versus no bevacizumab and to explore molecular biomarkers related to biology and outcome of inflammatory breast cancer.
A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Four Cycles of Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-positive or High-risk, Node-negative, HER2-low Invasive Breast Cancer
The purpose of this study is to determine whether the addition of trastuzumab to chemotherapy (TC or AC- >WP) improves invasive disease-free survival (IDFS) in women with resected node-positive or high-risk, node-negative breast cancer that is reported as HER2-low by all HER2 testing performed.
A Randomized Placebo-Controlled Trial of Omega-3 Fatty Acid for
the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness in Women with Early Stage Breast Cancer, Phase III
To assess if omega-3 fatty acid as compared to placebo causes a reduction in joint pain/stiffness in women with aromatase inhibitor (AI) associated arthralgias as measured at 12 weeks by the modified Brief Pain Inventory (BPI)
An Open-label, Multi-center, Extension Study of Trastuzumab-MCC-DM1 (T-DM1) Administered as a Single Agent or in Combination with Other Anti-cancer Therapies in Patients Previously Treated with the Equivalent T-DM1 Regimen in a Genentech and/or F. Hoffman-La-Roche LTD-sponsored T-DM1 Study
The purpose of this study is to provide continued T-DM1 therapy as single-agent T-DM1 or in combination with paclitaxel or with pertuzumab plus paclitaxel to HER2-positive breast cancer patients who were previously enrolled in a Genentech/Roche-sponsored T-DM1 study and who derived benefit from the therapy administered in the parent study.
Biobehavioral Mechanisms of Fatigue in Patients Treated on
NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Vs. Placebo on Recurrence and Survival in Early-Stage Breast Cancer
This companion study is primarily being conducted to understand the recovery from treatment-related fatigue. Specifically, the companion study is being done to determine if there are markers in blood cells that can explain why some women have persistent fatigue after breast cancer treatments.
E2108 A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
The purpose of this study is to evaluate whether early local therapy of intact primary disease in women with stage IV breast cancer whose disease does not progress during initial optimal systemic therapy will result in prolonged survival, compared to women who receive local therapy for palliation only.
I SPY 2 Trial Investigation of Series Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2
The purpose of this study is to determine whether adding experimental agents to standard neoadjuvant paclitaxel (with or without trastuzumab), doxorubicin and cyclophosphamide increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry, and to determine for each experimental agent used the predictive probability of success in a subsequent phase III trial for each possible biomarker signature.
RTOG 0413 NSABP B-39 A Randomized Phase III Study of Conventional Whole Breast Radiation vs. Partial Breast Radiation for Women with Stage 0, I or II Breast Cancer
The purpose of this study is to determine whether partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy provides equivalent local tumor control in the breast compared to conventional whole breast irradiation (WBI) in the local management of early stage breast cancer.
RTOG 1005 A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer.
To determine whether an accelerated course of hypofractionated WBI including a concomitant boost to the tumor bed in 15 fractions following lumpectomy will prove to be noninferior in local control to a regimen of standard WBI with a sequential boost following lumpectomy for early-stage breast cancer participants.
Targeting Notch Signaling and Hepatocyte Growth Factor in Breast Cancer
To analyze tumor specimens from breast cancer participants in order to further elucidate mechanisms of cancer stem cell activation and inhibition.
Cancer: Cervical
Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy
The purpose of this study is to determine if post-operative adjuvant chemo-radiation therapy can significantly improve recurrence-free survival when compared to radiation therapy alone in Stage I/IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy.
Cancer: Colon
A Phase III Trial of Six Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo For Patients With Resected Stage III Colon Cancer
The purpose of this study is to compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX) or standard chemotherapy (FOLFOX) with three years of celecoxib.
Cancer: Colorectal
A Randomized Phase II Study of Bevacizumab/mFOLFOX6 VS. Bevacizumab/FOLFIRI With Biomarker Stratification In Patients With Previously Untreated Metastatic Colorectal Cancer.
The primary purpose of this trial is to assess whether: expression of chemotherapy resistance marker ERCC-1 is associated with PFS in first-line metastatic CRC patients treated with bevacizumab in combination with mFOLFOX6 or FOLFIRI; and whether plasma level of vascular endothelial growth factor A (VEGF-A) as a potential biomarker for bevacizumab, and in combination with ERCC-1 expression as a chemotherapy regimen biomarker, is associated with different PFS.
A Randomized, Phase III Trial of mFOLFOX7 or XELOX Plus Bevacizumab Versus 5-Fluorouracil/Leucovorin or Capecitabine Plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer
The purpose of this study is to compare the progression-free survival (PFS) of elderly patients with metastatic colorectal carcinoma who are randomized to receive fluoropyrimidine-based therapy plus bevacizumab, with or without oxaliplatin.
Cancer: Esophageal
A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin and Radiation Therapy for Patients With Esophageal Cancer Who Are Treated Without Surgery.
The purpose of this study is to evaluate if the addition of cetuximab to paclitaxel, cisplatin and radiation improves overall survival compared to paclitaxel, cisplatin and radiation alone in patients with esophageal cancer who are treated without surgery.
A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-overexpressing Esophageal Adenocarcinoma
The purpose of this study is to determine if trastuzumab increases disease-free survival when combined with trimodality treatment (radiation plus chemotherapy followed by surgery) for patients with HER2-overexpressing esophageal adenocarcinoma.
Cancer: Gallbladder or Bile Duct
A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC).
The purpose of this study is to estimate the stratum-specific (RO and R1) and overall two-year survival probabilities of EHCC participants treated with adjuvant capecitabine/gemcitabine followed by capecitabine and radiotherapy.
Cancer: Gastric or Gastroesophageal Jct
A Phase II Study of MK-2206 (NSC-749607) as Second-line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer
The objectives of this study are to estimate the overall survival (OS) for patients with advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma treated with MK-2206, to estimate the progression-free survival (PFS) in this patient population, to estimate the response rate (confirmed and unconfirmed CR and PR by RECIST) in this patient population, and to assess the frequency and severity of toxicity associated with this regimen.
Cancer: Glioblastoma
An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (The “ACT IV” Study)
The primary objective of the study is to determine if the addition of rindopepimut/GM-CSF to adjuvant temozolomide improves overall survival in patients with newly diagnosed EGFRvIII positive glioblastoma who have undergone gross-total resection.
Cancer: Head and Neck
A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent Or Metastatic Head and Neck Cancer
The purpose of this study is: • To compare the overall survival of patients with recurrent or metastatic head and neck cancer treated with standard cisplatin-based chemotherapy with or without bevacizumab. • To assess toxicities with the addition of bevacizumab to each cisplatin-doublet (cisplatin/docetaxel and cisplatin/5-FU). • To compare the objective response rates and the progression-free survival achieved with the above therapies. • To collect blood samples before and after therapy for future correlative studies. • To collect tumor tissue samples available at baseline from prior diagnostic procedures for future correlative studies.
A Phase III Study of Post-operative RadiationTherapy +/- Cetuximab for Locally Advanced Resected Head and Neck Cancer.
The purpose of this study is to test whether the addition of cetuximab to radiation therapy will improve overall survival in post-operative patients with intermediate risk following surgery.
RTOG 1016 Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-associated Oropharynx Cancer.
The overall goal of this trial is to identify a less toxic approach in HPV-associated cancer of the oropharynx with the high survival currently associated with aggressive chemoradiation approaches. We aim to show that targeted bioradiation will substantially reduce the burden of acute toxicity, result in faster recovery and return to function, carry lower rates of late effects, and result in similar rates of long-term survivorship compared to conventional chemoradiation.
Cancer: Kidney
A Randomized Phase III Trial Comparing Everolimus Plus Placebo Versus Everolimus Plus Bevacizumab for Advanced Renal Cell Carcinoma Progressing after Treatment with Tyrosine Kinase Inhibitors
The purpose of this study is to compare the overall survival of patients receiving bevacizumab plus everolimus versus placebo plus everolimus among patients with advanced renal cell carcinoma progressing after first line VEGFR-TKI treatment.
Cancer: Kidney (Renal)
An Open-label, Multicenter Phase II Study to Compare the Efficacy and Safety of Everolimus as First-line Followed by Second-line Sunitinib Versus Sunitinib as First-line Followed by Second-line Everolimus in the Treatment of Patients With Metastatic Renal Cell Carcinoma
The purpose of this study is to assess the probability that progression-free survival during or after first-line of treatment (PFS-1L) in patients who receive Everolimus is non-inferior to the PFS during or after first-line of treatment in patients who receive sunitinib as treatment for metastatic renal cell carcinoma.
The key secondary objective is to compare the two treatment arms for a composite endpoint referred to as progression-free survival combined (PFS-C) and defined as the shorter time between randomization and a radiologically documented progression of disease during/after the second line or between randomization and death.
EVEREST: EVErolimus for Renal Cancer Ensuing
Surgical Therapy, a Phase III Study
The primary objective of this study is to compare recurrence-free survival in renal carcinoma patients randomly assigned to one year of everolimus versus one year of placebo after nephrectomy or partial nephrectomy.
Cancer: Leukemia
A Phase II Study of Epratuzumab (NSC-716711) in Combination with Cytarabine and Clofarabine for Patients with Relapsed or Refractory Ph-negative Precursor B-cell Acute Lymphoblastic Leukemia (ALL)
The primary objective of this study is to test whether the complete response (CR+Cri) rate among patients who have relapsed or refractory precursor B-cell ALL is sufficiently high to warrant further investigation.
A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Relapsed Acute Myelogenous Leukemia
The purpose of this study is to test whether the complete remission (CR) rate (including CR with incomplete recovery) in patients with relapsed acute myeloid leukemia treated with a combination of chemotherapy and pravastatin is sufficiently high to warrant phase III investigation.
A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin as Induction and Post-Remission Therapy in Participants Age 60 and Older with Previously Untreated Non-M3 Acute Myeloid Leukemia
The primary objective of this study is to test whether the induction regimen incorporating azacitidine and gemtuzumab ozogamicin is sufficiently safe and effective among older participants with previously untreated AML to warrant phase III study.
A Randomized, Prospective, Double-Blind, Placebo-Controlled,
Phase 3 Study of US-ATG-F Prophylaxis as a Supplement to Standard of Care Prophylaxis to Prevent Moderate to Severe Chronic Graft Vs. Host Disease (GVHD) in Individuals with Adult Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome after Allogeneic Stem Cell Transplantation from Unrelated Donors (IV-ATG-SCT-01).
The primary objective of this study is to demonstrate the efficacy of US-ATG-F vs. the placebo when combined with standard GVHD prophylaxis (TAC plus MTX) in moderate to severe chronic GVHD-free survival after allogeneic stem cell transplantation from unrelated donors. The secondary objective is to demonstrate that US-ATG-F treatment results in beneficial effects on GVHD prevention and to perform assessments related to the risk of mortality and relapse.
Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies
The purpose of this study is to determine patient outcomes following high dose combination chemotherapy treatment and to compare higher dose vincristine with compared to standard dose vincristine
Phase II Study of Combination of Hyper-CVAD and Dasatinib with or without Allogeneic Stem Cell Transplant in Patients with Philadelphia (Ph) Chromosome-positive and/or Bcr-Abl-positive Acute Lymphoblastic Leukemia (ALL) (A BMT Study)
The purpose of this study is to test whether or not the relapse-free survival after allogeneic stem cell transplantation among Philadelphia chromosome-positive and/or BCR/ABL-positive acute lymphoblastic leukemia (ALL) patients given an intensive short-term chemotherapy regimen of hyper-CVAD in combination with the tyrosine kinase inhibitor dasatinib is sufficiently high enough to warrant further investigation.
Phase III Randomized Trial of Clofarabine as Induction and Post-remission Therapy Versus Standard Daunorubicin and Cytarabine Induction and Intermediate-dose Cytarabine Post-remission Therapy, Followed by Decitabine Maintenance Versus Observation in Newly Diagnosed Acute Myeloid Leukemia in Older Adults (Age Greater Than or Equal to 60 Years)
The primary objective is to evaluate the effect of clofarabine induction and consolidation therapy on overall survival in comparison with standard therapy (daunorubicin and cytarabine) in newly diagnosed acute myeloid leukemia (AML) patients age greater than or equal to 60 years.
Treatment of Patients with Newly Diagnosed Standard Risk B-precursor Acute Lymphoblastic Leukemia (ALL)
The main objective of the study is to risk-stratify newly diagnosed children with standard-risk ALL (no more than 10 years old, white blood count less than 50K) using minimal residual disease by flow cytometry to assess rapidity or response as well as biologic determinants like phenotype and genotype.
Cancer: Liver
A Phase III, Randomized, Double-blind Trial of Chemoembolization with or without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients with and without Vascular Invasion
The purpose of this study is to compare progression-free survival (PFS) of chemoembolization alone to sorafenib in combination with chemoembolization.
Multi-center, Randomized Pilot Study of the Effect of Sorafenib-dosing
Schedule on Tolerability and Drug Delivery, Protocol: ONC 2010-19
The purpose of this trial is to evaluate the impact of dose ramp up for sorafenib on tolerability as measured by cumulative and median sorafenib dose delivered at month four of treatment.
Cancer: Lung
A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) -IIIA Non-Small Cell Lung Cancer (NSCLC)
This research is being done because even with the most aggressive after-surgery treatment with chemotherapy, many people still have the lung cancer recur. The purpose of this study is to determine if adding bevacizumab to chemotherapy improves the chance for cure for participants who have had complete surgical resection of their Stage IB-IIIA NSCLC.Bevacizumab is considered investigational drug in this study.
A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without COncurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Protocol S0819 Version Date: 7/29/09
The primary objective of this study is, in patients with advanced NSCLC treated with carboplatin, paclitaxel and bevacizumab (if appropriate) with or without cetuximab, to compare overall survival (OS) in the entire study population and progression-free survival (PFS) by institutional review in EGFR FISH-positive patients. The secondary objectives are, in patients with advanced NSCLC treated with carboplatin, paclitaxel and bevacizumab (if appropriate) with or without cetuximab, to compare OS and PFS by centralized review in EGFR FISH-positive patients and PFS by centralized image review and by institutional review in the entire study population; to compare the response rate (confirmed plus unconfirmed, complete and partial responses) in the subset of patients with measurable disease in EGFR FISH-positive patients and the entire study population; to assess the toxicities of these treatment regimens; to prospectively test EGFR FISH as a predictive marker for the selection of patients for cetuximab plus chemotherapy; to evaluate the role of KRAS mutations in terms of cetuximab efficacy; and to compare the results of EGFR FISH with KRAS mutations, EGFR mutations, EGFR IHC and other purported EGFR-related biomarkers.
Pazopanib and Weekly Paclitaxel in Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
The study will look at the safety and effectiveness of pazopanib given with paclitaxel in patients with advanced non small cell lung cancer. The purpose of this study is to evaluate the objective response rate of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Tumor response will be assessed according to the RECIST criteria (version 1.1). A subject is defined as a responder if he/she sustains a complete response (CR) or a partial response (PR) for at least four weeks at any time during treatment. A subject without a post-baseline assessment of response will be considered a non-responder.
Randomized, Phase III Trial of Gemcitabine/Carboplatin with or without BSI-201 (SAR240550) (a PARP1 Inhibitor) in Patients with Previously Untreated Stage IV Squamous Non-small-cell Lung Cancer (NSCLC)
The purposes of this study are to evaluate the overall survival (OS) of patients with stage IV squamous NSCLC receiving gemcitabine/carboplatin either with or without BSI-201 and to evaluate progression-free survival (PFS), time-to-progression (TTP), objective response rate (ORR), safety and tolerability of the treatment regimen, and quality of life as measured by EORTC QLC-30 and QLQ-LC13 in patients with stage IV squamous NSCLC receiving gemcitabine/carboplatin either with or without BSI-201.
Cancer: Lymphoma
A Phase I/II Trial of Vorinostat (SAHA) (NSC-701852) in Combination with Rituximab-CHOP in Patients with Newly Diagnosed Advanced Stage Diffuse Large B-cell Lymphoma (DLBCL)
The primary objective for the first phase is to find a safe dose of vorinostat to be used in combination with R-CHOP (vorinostat-R-CHOP). The primary objective for the second phase is to estimate the two-year progression-free survival rate in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) treated with vorinostat and R-CHOP therapy (vorinostat-R-CHOP).
A Phase II Trial of Response Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging
The purpose of this study is to estimate the two year progression-free survival in patients with advanced stage Hodgkin lymphoma treated with response-adapted therapy based on FDG-PET imaging after two cycles of ABVD.
A Phase II, Multi-center, Open-label Study of YM155 Plus Rituximab in Previously Treated Subjects with CD20-positive B-cell Non-Hodgkins Lymphoma (NHL) Who are Ineligible for or Who Have Previously Received an Autologous Stem Cell Transplant (ASCT)
The purposes of this study are to determine objective response rate and to evaluate the following:
Safety and tolerability of YM155 given in combination with rituximab; complete response (CR) rate; partial response (PR) rate; time to response; duration of response; clinical benefit rate; progression-free survival and overall survival.
A Phase IV, Multi-center, Randomized, Comparator Trial Evaluating the Standard Weight-based Dose (0.24 mg/kg) Compared to a Fixed Dose (20 mg) of Plerixafor Injection in Combination with G CSF to Mobilize and Collect =5 x 106 CD34+ cells/kg in = Four Days and to Evaluate the Difference in Total Systemic Exposure in Patients with Non-Hodgkin’s Lymphoma (NHL) Weighing =70 kg
The purpose of this study is to examine whether lower weight (=70 kg) NHL patients are more likely to achieve a target collection of =5 × 106 CD34+ cells/kg in = four days of apheresis following administration of a fixed 20 mg dose as compared with the standard weight-based dose of 0.24 mg/kg plerixafor in combination with G CSF.
A Randomized Phase II Trial of R-HCVAD/MTX/Ara-C Induction Followed by Consolidation With an Autologous Stem Cell Transplant Versus. R-Bendamustine Induction Followed by Consolidation With an Autologous Stem Cell Transplant for Patients = 65 Years of Age with Previously Untreated Mantle Cell Lymphoma.
1.The primary objective of this study is to estimate the two-year Progression Free Survival (PFS) in patients with newly diagnosed mantle cell lymphoma (MCL) treated with RHCVAD/ MTX/Ara-C + autologous stem cell transplant or R-bendamustine + autologous stem cell transplant and to select a regimen for further development. 2.To assess the response rate and overall survival of patients with newly diagnosed MCL treated with R-HyperCVAD/MTX/Ara-C + autologous stem cell transplant or R-bendamustine + autologous stem cell transplant. 3. To assess the toxicity and tolerability of R-HyperCVAD/MTX/Ara-C + autologous stem cell transplant or R-bendamustine + autologous stem cell transplant in patients with newly diagnosed MCL. 4. To bank diagnostic tissue sections, peripheral blood prior to treatment, at restaging, at the end of induction and after transplant for future translational research studies.
A Randomized, Double-blind, Placebo-controlled Phase III Study of SGN-35 (Brentuximab Vedotin) and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin’s Lymphoma (HL) Following Autologous Stem Cell Transplant (ASCT)
Primary: • To compare the progression-free survival (PFS) of SGN-35 and best supportive care (BSC) versus placebo and BSC Secondary: • To compare overall survival (OS) between the two treatment arms • To evaluate the safety and tolerability of SGN-35 compared to placebo • To characterize the incidence of anti-therapeutic antibodies (ATA)
CALGB 50303/CTSU50303 Phase III Randomized Study of R-CHOP v. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-cell Lymphomas
The purpose of this study is to compare the effects of two treatments; R-CHOP with Dose-Adjusted EPOCH-R for untreated de novo DLBC lymphoma and to develop molecular predictor of outcome using molecular profiling.
CRAD001N2301 A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Complete Response (CR) With First-line Rituximab-chemotherapy (R-CHOP) Achieved
The purpose of this study is to compare the efficacy and safety of RAD001 10 mg p.o. daily dose against matching placebo as adjuvant therapy in poor risk patients with DLBCL who have achieved CR after first-line R-CHOP.
Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients with Relapsed Follicular Non-Hodgkin’s Lymphoma Beyond First Complete Response
BMT CTN PROTOCOL 0701
The primary objective of this study is to measure progression-free survival at two years after non-myeloablative HSCT with a pre-transplant conditioning regimen of fludarabine, cyclophosphamide and rituximab (FCR).
Phase II Trial of Response-adapted Chemotherapy Based on Positron Emission Tomography for Non-bulky Stage I and II Hodgkin’s Lymphoma (CALGB 50604)Version 4/21/2010
The purpose of this study is to determine PFS from enrollment for patients with non-bulky stage I and II Hodgkin’s lymphoma. All patients will begin treatment with ABVD. The chemotherapy regimen (ABVD or escalated BEACOPP) and the possible addition of involved-field radiation therapy will be determined by response as assessed by PET imaging after two cycles. The primary endpoint will be PFS for patients that are PET-negative following two cycles of ABVD and for whom treatment will consist of two additional cycles of ABVD without radiation therapy.
Temsirolimus for Relapsed/Refractory Hodgkins Lymphoma
The primary objective of this study is to estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus, evaluate the toxicity of temsirolimus in this patient population, estimate the time to progression and overall survival after treatment with temsirolimus
Cancer: Lymphoma and Leukemia
Sanofi Aventis, ARD12130
A Phase 2 study of SAR245409 in patients with relapsed or refractory mantle cell lymphoma, follicular lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma
To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in patients with one of the following relapsed or refractory lymphoma or leukemia subtypes: mantle cell lymphoma (MCL), follicular lymphoma (FL), or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
Cancer: Lymphoma, Leukemia
A Phase I Trial to Determine Safety and Tolerability of Ex Vivo Expanded Human Myeloid Progenitor Cells (CLT-008) Infused 24 Hours Post-Transplant to Support Allogeneic Umbilical Cord Blood Transplantation for Hematologic Malignancies
The primary objective of this study is to determine the safety and tolerability of single-donor and pooled-donor ex vivo expanded human myeloid progenitor cells (CLT-008) when administered 24 hours after a umbilical cord blood (UCB) transplant.
Cancer: Multiple Myeloma
An Open-label Phase I/II Study of Bendamustine, Weekly Bortezomib, Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
The primary objective of the phase I portion of this study is to determine a maximally tolerated dose of bendamustine when used in combination with weekly bortezomib, lenalidomide and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma. The primary objective of the phase II portion of this study is to determine the overall response rate, partial response, very good partial response, stringent complete response and complete response in patients treated with bendamustine in combination with weekly bortezomib, lenalidomide and dexamethasone.
High-dose Busulfan and Melphalan followed by Bortezomib (BuMelVel) as Conditioning in Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma using Circulating Endothelial Cells as a Surrogate of Disease Activity
The purpose of this study is to evaluate the effectiveness of high-dose busulfan and melphalan followed by bortezomib as conditioning in autologous peripheral blood stem cell transplantation for patients with multiple myeloma using circulating endothelial cells as a surrogate of disease activity.
Cancer: Pancreatic
A Phase III Trial Evaluating Both Erlotinib and Chemo-radiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma
The purposes of this study are to determine whether the addition of erlotinib to gemcitabine adjuvant chemotherapy improves survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head, neck and uncinate process) and to determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine-based chemotherapy further enhances survival for such patients who are without evidence of progressive disease after five cycles of gemcitabine-based chemotherapy.
A Pilot Study Evaluating Intratumoral Administration of Autologous KLH-pulsed Dendritic Cell Vaccine Following Stereotactic Radiation for Locally Advanced Pancreatic Adenocarcinoma
The hypothesis of this proposal is that intratumoral injection of KLH-pulsed dendritic cells (DCs) after hypofractionated stereotactic radiotherapy is safe and is associated with a reduction in tumor volume. The mechanism, we hypothesize, is that radiation for pancreatic ductal adenocarcinoma leads to release of tumor antigens that are picked up by locally injected DCs resulting in local stimulation of anti-tumor T-cell responses. This may lead to reduction in tumor volume and subsequent potential for resection of the tumor, and may lead toward an improved long-term survival in patients with advanced pancreatic adenocarcinoma.
Cancer: Prostate
A Phase III Trial of Short-term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients with Rising PSA after Radical Prostatectomy
The purposes of this study are to determine whether the addition of neoadjuvant and concurrent short-term androgen deprivation (NC-STAD) to prostate bed radiation therapy (PBRT) improves freedom from progression (FFP) (maintenance of a PSA less than the nadir=2 ng/mL, absence of clinical failure and absence of death from any cause) for five years over that of PBRT alone in men treated with salvage radiation therapy (RT) after radical prostatectomy, and to determine whether NC-STAD plus pelvis lymph node radiation therapy (PLNRT) plus PBRT improves FFP over that of NC-STAD plus PBRT and PBRT alone in men treated with salvage RT after radical prostatectomy.
A Phase III, Prospective, Randomized Trial of Dose-escalated Radiotherapy with or without Short-term Androgen Deprivation Therapy for Patients with Intermediate-risk Prostate Cancer.
The purpose of this study is to demonstrate an overall survival (OS) advantage for the addition of short-term (six months) androgen deprivation therapy (ADT) to dose-escalated radiotherapy (RT) for patients with intermediate-risk prostate cancer. The events for OS will be defined as death due to any cause.
A Randomized Phase II Study of Androgen Deprivation Combined with IMC-A12 Versus Androgen Deprivation Alone for Patients with New Hormone-sensitive Metastatic Prostate Cancer
The primary objective of this study is to compare the undetectable PSA rate (PSA < 0.2 ng/mL) after seven cycles (28 weeks) of protocol treatment between those randomized to a hormone agonist and bicalutamide and those randomized to a hormone agonist, bicalutamide and IMC-A12.
Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More than Four Following Initial Androgen Deprivation Therapy, Phase II
The primary objective is to assess the rate of achieving a PSA of = 0.2 ng/ml with abiraterone acetate therapy in men with metastatic prostate cancer with a suboptimal response to androgen deprivation therapy (ADT). The undetectable level of PSA will be confirmed by a second measurement with a PSA = 0.2 ng/ml at least 4 weeks later, without any evidence for progression. Participants who fail to reach and confirm a PSA of = 0.2 ng/ml by 12 months will be considered a non-responder with regard to the primary endpoint.
Cancer: Prostate Cancer
A Registry of Sipuleucel-T Therapy in Men with Advanced Prostate Cancer
The goal of this trial is to further quantify the risk of cerebrovascular events (CVEs) following sipuleucel-T therapy for all subjects.
Cancer: Rectal
A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer
The purpose of this study is to assess the pathologic complete response rate in participants with adenocarcinoma of the rectum, Stages II and III with wild-type K-ras treated with the combination of oxaliplatin, capecitabine and cetuximab given alone and given concomitantly with external beam radiation (EBRT), followed by surgery.
Cancer: Renal and Melanoma
Proleukin (Interleukin-2) Observational Registry to Evaluate the
Treatment Patterns and Clinical Response in Malignancy
The goal of this registry is to establish a standardized source of observational data that can be used to report and query patient-care patterns, clinical outcomes and trends from HD IL-2 therapy in treating mM, mRCC or other malignancies.
Cancer: Salivary Gland
A Randomized, Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-risk Malignant Salivary Gland Tumors.
The purpose of this study is to determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors and to acquire preliminary efficacy data comparing post-operative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.
Cancer: Skin
A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Vs. High-Dose Interferon a- 2b for Resected High-Risk Melanoma.
The purpose of this study is to evaluate recurrence-free survival (RFS) between participants randomized to receive post-operative adjuvant ipilimumab vs. those randomized to receive HDI and to evaluate overall survival (OS) between individuals randomized to receive post-operative adjuvant ipilimumab vs. those randomized to receive HDI.
The High-Dose Aldesleukin (IL-2) “SELECT” Trial: A Prospective Tissue Collection Protocol to Investigate Predictive Models of Response to High-Dose IL-2 Treatment in Patients with Advanced Melanoma.
To determine if DASL subclassification can identify a group of patients with advanced melanoma who are significantly more likely to respond to high-dose IL-2-based therapy (Class 2) than the historical 16% response rate in an unselected patient population.
Cancer: Uterine
A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients with High Risk, Early Stage Endometrial Carcinoma
The purpose of this study is to determine if treatment with vaginal cuff brachytherapy followed by three cycles of chemotherapy reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to pelvic radiation therapy.
GOG 0261, A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naïve Patients With Newly Diagnosed Stage I-IV Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus
The purpose of this study is to determine if treatment with a combination of paclitaxel and carboplatin chemotherapy does not result in an inferior mortality rate when compared to ifosfamide, mesna and paclitaxel chemotherapy.
Cardiovascular Health
Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA Trial)
The CABANA trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation. The CABANA trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for reducing total mortality in patients with untreated or incompletely treated atrial fibrillation.
Cardiovascular: Marfan Syndrome
Aortic Valve Operative Outcomes in Marfan Patients
The purpose of the study is to: -Evaluate and compare operative outcomes of the aortic valve-sparing (AVS) and aortic valve replacement (AVR) surgical interventions in different categories of patients with Marfan syndrome and estimate predictors of the surgical outcomes; - Compare the outcomes described in above objective in different categories of patients with Marfan syndrome who underwent the AVS or the AVR surgical intervention; - Determine predictors that have prognostic importance for the outcomes of surgical interventions in different categories of patients with Marfan syndrome who underwent the AVS or the AVR surgical intervention; - Evaluate prevalence of different types of AVR and AVS operations in patients with Marfan syndrome who had surgical intervention for correction of aortic valve abnormalities; - Evaluate indications used to perform AVR and AVS operations in patients with Marfan syndrome; - In different categories of patients with Marfan syndrome who underwent the AVS or the AVR surgical intervention, estimate: a) short-term morbidity & mortality in patients with Marfan syndrome undergoing the AVS or the AVR surgical intervention; b) cumulative incidence of selected complications estimated from the 24 month follow-up period; c) freedom from selected complications estimated from the 24 month follow-up period; d) survival rate estimated from the 24 month follow-up period; e) Quality of life score Develop a centralized on-line database for accumulation of data on patients with Marfan syndrome undergoing the AVS or the AVR surgery; - Develop a repository for blood and tissue samples obtained from study participants.
Endocrinology: Growth Hormone
The Global Hypopituitary Control and Complications Study (HypoCCS)
The primary objective of the study is to determine whether long-term growth hormone (GH) replacement therapy administered in clinical practice to adults with growth hormone deficiency (GHD) is associated with increased or decreased incidences of clinically significant adverse events (AEs).
Eye Disease
Evaluation of Heavy Metals in Human Ocular Fluids and Tissue
The purpose of this study is to ascertain levels of various heavy metals in the human eye.
For study flier
Quality of Life and Type 2 Diabetes: An Observational Study According to Type of Insulin Management
Primary aims are to describe the multidimensional aspects of quality of life in persons with type 2 diabetes according to type of insulin management (none, basal only, basal-bolus), and to determine if type of insulin management significantly impacts health-related quality of life for people with type 2 diabetes.
Infectious Disease: HIV
A Phase III, Randomized, Double-blind Study of the Safety and
Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen over 48 Weeks in HIV-1-infected, Integrase Inhibitor-naïve, Anti-retroviral Therapy-experienced Adults
The purpose of this study is to test the efficacy of GSK1349572 (the study drug) and to see how well it works in comparison to raltegravir, an integrase inhibitor that is avaliable for use for HIV.
Infectious Disease: Influenza
A Randomized, Multicenter, Single-blinded, Parallel Study of the Safety of 100 mg and 200 mg Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged Greater Than or Equal To 13 Years, protocol NV25118
The purpose of this study is to evaluate the safety of intravenous oseltamivir.
Internet (Craigslist)
Insulin Resistance Intervention after Stroke (IRIS) Trial
Pioglitazone is a medication given to diabetics from blood glucose control. It has not been tested versus placebo for the overall risk of decreasing fatal/non-fatal stroke or fatal/non-fatal MI among non-diabetic men and women with insulin resistance.
Mental Health
Cyclooxygenase-2-inhibitor Combination Treatment for Bipolar Depression: Role of Inflammation and Kynurenine Pathway Biomarkers
This trial aims to investigate the effects of celecoxib as an add-on therapy for non-responding bipolar depression treated with other antidepressants. The study will enroll bipolar depressed individuals who have failed to remit in response to antidepressant therapy, or individuals who are experiencing a breakthrough of depressive symptoms in spite of being maintained on a mood stabilizer.
Cyclooxygenase-2-inhibitor Combination Treatment for Bipolar Depression: Role of Inflammation and Kynurenine Pathway Biomarkers
This trial aims to investigate the effects of celecoxib as an add-on therapy for non-responding bipolar depression treated with other antidepressants. The study will enroll bipolar depressed patients who have failed to remit in response to antidepressant therapy, or patients who are experiencing a breakthrough of depressive symptoms in spite of being maintained on a mood stabilizer.
Mental Health: Depression
Non-invasive pulse-wave analysis to test endoethelial function in depressed subjects.
The purpose of this study is to evaluate endothelial function in patients diagnosed with Major Depressive Disorder (MDD) using applanation tonometry to compute pulse wave velocity and index of augmentation.
Neurology: Arterio-vascular Malformation
A Randomized Multicenter Clinical Trial of Unruptured Brain
Arteriovenous malformations (BAVMs)
The study was developed to determine whether medical management improves long-term outcomes of patients with unruptured BAVMs compared to interventional therapy (endovascular procedures, neurosurgery or radiotherapy, alone or in combination). One may reduce the risk of death or stroke.
Pulmonary: Fibrosis
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis, Protocol Number: PIPF-016
The purpose of this research is to assess the safety and efficacy of pirfenidone when compared with a placebo in patients with idiopathic pulmonary fibrosis (IPF). The primary outcome measure assessed is the change in percent predicted forced vital capacity (percent FVC).
Skin Health: Psoriasis
A Multicenter, Open Registry of Patients With Psoriasis Who Are
Candidates for Systemic Therapy Including Biologics, Protocol
Number: C0168Z03
The registry study will track the behavior of the disease in response to other therapies, such as adalimumab, alefacept, certolizumab pegol, efalizumab, etanercept and other biologics. The registry also will evaluate clinical outcomes, quality of life and potential risks for patients who may receive standard therapies for psoriasis.
CLINICAL STUDY PROTOCOL P10-023 A 10-Year, Post-marketing, Observational, Registry of Adalimumab in Adult Patients.
The purpose of this registry is to observe the degree of long-term safety of adalimumab and how well it works to treat chronic plaque psoriasis for up to ten years. Adalimumab is a marketed drug for psoriasis. No medication is provided for this registry.
Stroke
Albumin in Acute Stroke (ALIAS) Trial: A Phase III Randomized Multicenter Clinical Trial of High-Dose Human Albumin Therapy for Neuroprotection in Acute Ischemic Stroke
Neuroprotective agents for acute ischemic stroke have thus far failed to be proven effective. Albumin versus placebo is the next step in trying to find a valid treatment for stroke victims.
Insulin Resistance Intervention after Stroke (IRIS) Trial
Pioglitazone is a medication given to diabetics from blood glucose control. It has not been tested versus placebo for the overall risk of decreasing fatal/non-fatal stroke or fatal/non-fatal MI among non-diabetic men and women with insulin resistance.
Transplant: Kidney
A Phase Ib, Randomized, Double-blind, Parallel-group, Placebo-controlled, Single-dose, Pharmacokinetic, Pharmacodynamic, Safety and Tolerability Study of ASKP1240 in de Novo Kidney Transplantation (Protocol 7163-CL-0103)
The purpose of this study is to assess the Pharmacokinetic (PK), Pharmacodynamic (PD), safety, and tolerability of a single dose of ASKP1240 when administered with standard immunosuppressants to subjects who receive a de novo kidney transplant.
The PK and PD parameters determined in de novo transplant subjects will be compared to the PK and parameter from the FIH Study 7163-CL-0101.
The purpose of the optional genetic study is to determine the correlation between genetics and the success or failure of ASKP1240.
Transplant: Lung
A Multi-center, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected with Respiratory Syncytial Virus (RSV) ALN-RSV01-109
This purpose of this study is to determine the effects (both good and bad) of ALN RSV01 for the treatment of RSV.
Web
Maintenance Therapy with Azacitadine and Valproic Acid after Allogeneic Stem Cell Transplant in Participants with High-Risk Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Primary Objective: To assess the combination of valproic acid and azacitadine in preventing relapse in participants with high-risk acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) after allogeneic stem cell transplant. The primary objective of this study is to determine the one-year overall survival rate from combining valproic acid (VPA) with 5-azacytidine (5-aza).
Secondary Objectives: To assess the effect of adding valproic acid to azacitadine on the following endpoints : Progression-free survival rates Incidence of malignant relapse at one year Probabilities of disease-free survival at one year
LOYOLA UNIVERSITY HEALTH SYSTEM
