Rituximab and Oblimersen in Treating Patients With Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma

Stopped early · Phase 2

Conditions studied: Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma

In brief

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 cancer-killing substances to them. Oblimersen may help rituximab work better by making cancer cells more sensitive to the drug. This phase II trial is studying how well giving rituximab together with oblimersen works in treating patients with stage II, stage III, or stage IV follicular non-Hodgkin's lymphoma

Key facts

Study ID

NCT00301795

Run by

National Cancer Institute (NCI)

People needed

52

Starts

2006-03-01

Last updated by the study team

2013-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Cancer and Leukemia Group B — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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