Stage IV Grade 1 Follicular Lymphoma Clinical Trial
Official title:
A Phase II Trial of Rituximab + Oblimersen Sodium (GenasenseTM, G3139, NSC #683428, IND #58842) in Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)
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
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
differentiation 20 positive (CD20+) follicular non-Hodgkin lymphoma (NHL) patients.
II. To determine the time to progression after rituximab + oblimersen sodium extended
induction therapy in previously untreated CD20+ follicular NHL patients.
SECONDARY OBJECTIVES:
I. To determine the toxicity profile of rituximab + oblimersen sodium therapy in previously
untreated CD20+ follicular NHL patients.
II. To establish whether the therapeutic effects of the rituximab + oblimersen sodium
combination are sufficiently promising to warrant evaluation in a subsequent randomized
trial (in comparison to rituximab alone).
III. To correlate Fc receptor profiling to response to rituximab + oblimersen sodium in
previously untreated patients with follicular NHL.
IV. To determine the relationship between change in fludeoxyglucose F 18 (FDG) uptake early
after treatment with rituximab + oblimersen sodium to response rate and time to progression.
OUTLINE: This is a multicenter study.
Induction therapy (month 1): Patients receive oblimersen IV continuously on days 1-7 and
15-21 and rituximab IV on days 3, 10, 17, and 24 in month 1.
Extended induction therapy (months 3, 5, 7, and 9): Patients receive oblimersen IV
continuously on days 22-28 and rituximab IV on day 24 in months 3, 5, 7, and 9.
Treatment continues for 9 months in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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