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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Cancer and Leukemia Group B Eastern Cooperative Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006721 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: tositumomab and iodine I 131 tositumomab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Phase III Trial of CHOP Plus Rituximab vs CHOP Plus Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas |
| Estimated Enrollment: | 500 |
| Study Start Date: | March 2001 |
| Estimated Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I (CHOP only): Active Comparator
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02) |
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: prednisone
Given orally
Drug: vincristine sulfate
Given IV
|
|
Arm II (CHOP + rituximab): Experimental
Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141.
|
Biological: rituximab
Given IV
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: prednisone
Given orally
Drug: vincristine sulfate
Given IV
|
|
Arm III (CHOP + tositumomab): Experimental
Patients receive chemotherapy as in arm I and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141.
|
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: prednisone
Given orally
Drug: vincristine sulfate
Given IV
Radiation: tositumomab and iodine I 131 tositumomab
Given IV
|
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether microglobulin is greater than upper limit of normal (yes vs no). Patients are randomized to 1 of 3 treatment arms. (Arm I closed to accrual as of 12/15/02)
Patients are followed on day 200, at 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 500 patients (250 per treatment arm) will be accrued for this study within 5.5 years. (Arm I closed to accrual as of 12/15/02)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed previously untreated bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No impaired cardiac status, including:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
No prior chemotherapy for lymphoma
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 259 Study Locations| Study Chair: | Oliver W. Press, MD, PhD | Fred Hutchinson Cancer Research Center |
| Study Chair: | Myron S. Czuczman, MD | Roswell Park Cancer Institute |
| Study Chair: | Sandra J. Horning, MD | Stanford University |
More Information
| Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
| Study ID Numbers: | CDR0000068321, SWOG-S0016, CALGB-50102, ECOG-SWOG-S0016 |
| Study First Received: | December 6, 2000 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006721 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II grade 3 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma |
|
Anti-Inflammatory Agents Anti-Infective Agents Prednisone Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Iodine-131 anti-B1 antibody Lymphoma, Follicular Cyclophosphamide Antibiotics, Antineoplastic Hormones Antibodies, Monoclonal Therapeutic Uses |
Iodine Micronutrients Lymphoma Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Growth Substances Mitosis Modulators Vincristine Trace Elements Antimitotic Agents Glucocorticoids |