Status:
COMPLETED
Oblimersen, Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 r...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of oblimersen when given in combination with rituximab, ifosfamide, carboplatin, and etoposide in patients with relapsed or refractory aggr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00086944
Start Date
May 1 2004
Last Update
January 24 2013
Active Locations (1)
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1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470