Cancer

Title
A Study Combining Vorinostat with Rituximab, Cyclophosphamide, Doxorubicin, Prednisone and Vincristine
Trial Number
203534051811
Number of Participants
75
Principal Investigator

Scott Smith

M.D.,Ph.D., FACP
Hematology/Oncology
Associate Professor
Eligibility

Adults = 18 years of age must have newly diagnosed diffuse large B-cell lymphoma (DLBCL) with stage II bulky, stage III or stage IV disease, with an IPI or R-IPI score greater than 0; Zubrod performance status of 2 or better; unilateral bone marrow aspirate and biopsy for staging performed within 42 days prior to registration; no clinical evidence of central nervous system involvement by lymphoma; no prior chemotherapy, radiation or antibody therapy for lymphoma; absolute neutrophil count (ANC) > 1,000/mcl and platelets > 100,000/mcl within 28 days prior to registration, unless due to bone marrow infiltration by lymphoma; measurable disease determined by CT scan of chest, abdomen and pelvis performed within 28 days prior to registration; cardiac ejection fraction = institutional lower limit of normal (ILLN) by MUGA scan or 2-D ECHO with no significant abnormalities within 42 days prior to registration; no other prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years; must not be pregnant or nursing; must not be HIV-positive.

Purpose

The purpose of this study is to determine the safety, effectiveness and maximum tolerated dose of vorinostat in combination with rituximab, cyclophosphamide, doxorubicin, prednisone and vincristine.

Enrollment

(708) 327-3142

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