Rituximab and Oblimersen in Treating Patients With Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma
NCT ID: NCT00301795
Last Updated: 2013-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
52 participants
INTERVENTIONAL
2006-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (oblimersen sodium and rituximab)
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.
oblimersen sodium
Given IV
rituximab
Given IV
laboratory biomarker analysis
Correlative studies
Interventions
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oblimersen sodium
Given IV
rituximab
Given IV
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Barbara Grant
Role: PRINCIPAL_INVESTIGATOR
Cancer and Leukemia Group B
Locations
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Cancer and Leukemia Group B
Chicago, Illinois, United States
Countries
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Other Identifiers
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CALGB 50404
Identifier Type: -
Identifier Source: secondary_id
CDR0000462385
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-03080
Identifier Type: -
Identifier Source: org_study_id
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