Oblimersen, Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Completed · Phase 1/Phase 2
Conditions studied: Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma
In brief
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
Key facts
- Study ID
- NCT00086944
- Run by
- National Cancer Institute (NCI)
- People needed
- 25
- Starts
- 2004-05-01
- Last updated by the study team
- 2013-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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