NCT00290472
CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
PHASE2
COMPLETED
NCT00290472
INTERVENTIONAL
A Phase II Study of CCI-779 in B-cell Lymphoma and CLL
Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Inclusion Criteria:
* Histologically or cytologically confirmed B-cell non-Hodgkin's lymphoma, including the following subtypes:
* Aggressive B-cell lymphoma (Group A)
* Diffuse large B-cell lymphoma
* Transformed lymphoma
* Follicular lymphoma (Group B)
* Small lymphocytic lymphoma
* Chronic lymphocytic leukemia (CLL) (Group C)
* Other B-cell small lymphocytic disorders
* No mantle cell lymphoma
* No potentially curative treatment options because of lack of response, relapse, or ineligibility
* Relapsed or refractory disease
* Patients with refractory disease (i.e., less than a partial response to the last treatment) must have received no more than 3 prior regimens (group A)
* Patients with sensitive disease (i.e., at least a partial response to the last treatment) must have received no more than 4 prior regimens (group A)
* Patients who have failed prior autologous transplantation are eligible (group A)
* No more than 5 prior regimens (groups B and C)
* The salvage regimen, conditioning regimen, and any maintenance therapy are considered 1 regimen
* Prior rituximab or alemtuzumab is not considered prior therapy
* No limitation to the amount of prior radiotherapy
* No CNS involvement
* Performance status: ECOG 0-2 OR Karnofsky 60-100%
* Life expectancy more than 3 months
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No prior allergic reactions attributed to compounds of similar chemical or biological composition to CCI-779
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix Completed therapy and considered \< 30% risk of relapse
* No other concurrent uncontrolled illness
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent prophylactic hematopoietic colony-stimulating factors
* No concurrent pegfilgrastim
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* More than 4 weeks since prior radiotherapy and recovered
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent unconventional therapies, food, or vitamin supplements containing Hypericum perforatum (St. John's wort)
* No other concurrent known inducers of CYP3A4
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* Measurable disease\*
* At least 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan \[Note: \*Only bone marrow or peripheral blood involvement required for CLL and Waldenstrom's macroglobulinemia \]
* Absolute neutrophil count \>= 1,000/mm3
* Bilirubin =\< 1.5 times upper limit of normal (ULN)
* AST and ALT =\< 2.5 times ULN
* Creatinine =\< 1.5 times ULN
* Fasting cholesterol =\< 350 mg/dL
* Fasting triglycerides =\< 400 mg/dL
* Platelet count \>= 50, 000/mm3 (\> 20,000/mm3 for patients with thrombocytopenia due to bone marrow involvement)
B-cell Chronic Lymphocytic Leukemia
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Malignant Neoplasm
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Splenic Marginal Zone Lymphoma
Waldenström Macroglobulinemia
- TREATMENT
-
- Type: DRUG
- Name: temsirolimus
- Description:
- Arm Group Labels: Arm I
- National Cancer Institute (NCI)