Status:
TERMINATED
Rituximab and Oblimersen in Treating Patients With Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry can...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the response rate (overall and complete response rate) after rituximab + oblimersen sodium extended induction therapy in previously untreated cluster of differenti...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Previously untreated, histologically confirmed follicular lymphoma, WHO classification, grade 1, 2, or 3a (\> 15 centroblasts per high power field with centrocytes present) which is stage III, IV, or bulky (i.e., single mass \>= 7 cm in any unidimensional measurement) stage II
- Institutional flow cytometry or immunohistochemistry must confirm CD20 antigen expression
- Patients classified as high risk according to the Follicular Lymphoma International Prognostic Index (FLIPI) should be considered for CALGB 50102/SWOG S0016
- No prior therapy for non-Hodgkin lymphoma including chemotherapy, radiation or immunotherapy (e.g., monoclonal antibody-based therapy)
- No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease
- ECOG performance status 0-2
- Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass \> 1 cm is acceptable; lesions that are considered non-measurable include the following:
- Bone lesions (lesions if present should be noted)
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Bone marrow (involvement by non-Hodgkin lymphoma should be noted)
- No known CNS involvement by lymphoma
- No known HIV infection
- Non-pregnant and non-nursing; women and men of reproductive potential should agree to use an effective means of birth control throughout their participation in this study; appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)
- Patients with a "currently active" second malignancy, other than nonmelanoma skin cancers are not eligible; (this includes Waldenstrom's Macroglobulinemia, since such patents have experienced transient increases in IgM following initiation of rituximab, with the potential for hyperviscosity syndrome requiring plasmapheresis); patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy, and are considered by their physician to be at less than 30% risk of relapse
- ANC \>= 1000/uL
- Platelet count \>= 50,000/uL
- Creatinine =\< 2 x ULN
- Total bilirubin =\< 2 x ULN; unless attributable to Gilbert's disease
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00301795
Start Date
March 1 2006
Last Update
January 7 2013
Active Locations (1)
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1
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606