Oblimersen, Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I/II trial is studying the side effects and best dose of oblimersen when given together with rituximab and combination chemotherapy and to see how well they work in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Carboplatin; Etoposide; Etoposide phosphate; Ifosfamide; Lenograstim; Oblimersen; Rituximab

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