A Phase I/II Study of G3139 (Genasense) in Combination With RICE Chemotherapy in Relapsed B-Cell Non-Hodgkin's Lymphoma

Fecha de inicio: 1 de mayo de 2004

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