Oblimersen, Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma
About this trial
This is an interventional treatment trial for Recurrent Adult Diffuse Large Cell Lymphoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma Any 1 one of the following histological subtypes for phase I: Grade 3 follicular center lymphoma Diffuse large B-cell lymphoma Transformed follicular lymphoma Mantle cell lymphoma Primary mediastinal B-cell lymphoma Any 1 of the following histological subtypes for phase II: Diffuse large B-cell lymphoma Transformed follicular lymphoma Primary mediastinal B-cell lymphoma Measurable disease At least 1 bidimensionally measurable lesion ≥ 10 mm in longest diameter by CT scan, MRI, x-ray, or clinical exam Relapsed disease after 1, and only 1, prior anthracycline-based chemotherapy regimen No known brain metastases Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% More than 3 months Absolute neutrophil count ≥ 1,000/mm^3* Platelet count ≥ 100,000/mm^3* Bilirubin normal** AST and ALT ≤ 2.5 times upper limit of normal PT and PTT normal Creatinine normal Creatinine clearance ≥ 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reactions attributed to compounds of similar chemical or biological composition to oblimersen or other study drugs No currently active second malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix Must have completed any prior therapy for a second malignancy and is considered to be at < 30% risk of relapse No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness Prior rituximab allowed No other concurrent immunotherapy See Disease Characteristics At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No other concurrent chemotherapy No concurrent hormonal therapy At least 4 weeks since prior radiotherapy and recovered No concurrent therapeutic radiotherapy At least 4 weeks since prior surgery No prior oblimersen or other antisense oligonucleotide therapy No other concurrent anticancer agents or therapies No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents
Sites / Locations
- University of Chicago Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (genase, combination chemotherapy)
See detailed description.