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Sponsored by: |
Cancer Biotherapy Research Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004039 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining interferon alfa or the monoclonal antibody rituximab with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy plus interferon alfa or rituximab in treating patients who have high risk stage III or stage IV lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: recombinant interferon alfa Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trials of CHOP Chemotherapy and Interferon Alpha or Rituximab Anti-CD20 Monoclonal Antibody as Initial Treatment of Patients With Stage III and IV High-Risk Indolent B-Cell Lymphoma and Intermediate Grade B-Cell Lymphoma |
Estimated Enrollment: | 80 |
Study Start Date: | June 1998 |
OBJECTIVES: I. Determine the toxicity of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with either interferon alfa or rituximab in patients with stage III or IV high risk indolent or intermediate B-cell lymphoma. II. Determine the objective tumor response rate and duration of response for these regimens in these patients. III. Determine the failure free survival and overall survival for these patients on these regimens. IV.
Compare the response rate and survival rate of these patients on these regimens to similar patients treated in published studies. V. Compare the toxicities of these regimens in these patients. VI. Determine the quality of life of these patients on these regimens.
OUTLINE: This is a multicenter study. Patients are assigned to one of two treatment arms: Arm I: Patients receive rituximab IV on day 0, and cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, followed by oral prednisone on days 1-5. Arm II: Patients receive interferon alfa subcutaneously on days 22-26, and cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, followed by oral prednisone on days 1-5. Treatment repeat every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and prior to chemotherapy for each course. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per treatment arm) will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed high risk (stage III or IV) indolent or intermediate (stage II to IV) B-cell lymphoma Small cleaved cell lymphoma Waldenstrom's macroglobulinemia Follicular small cleaved cell or mixed cell Follicular large cell Diffuse Immunoblastic High risk is defined as: Increased LDH OR Increased beta-2-microglobulin OR B symptoms OR Bulky disease of greater than 7 cm in diameter OR Extranodal disease other than blood or bone marrow involvement OR Mantle zone histology At least 1 lymph node or visceral lesion at least 2 cm in diameter
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No active infection or other medical condition this is lifethreatening Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: No prior therapy for lymphoma
United States, California | |
Hoag Memorial Hospital Presbyterian | |
Newport Beach, California, United States, 92658 |
Study Chair: | Robert O. Dillman, MD, FACP | Cancer Biotherapy Research Group |
Study ID Numbers: | CDR0000066762, CBRG-9807, NCI-V98-1494 |
Study First Received: | December 10, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004039 History of Changes |
Health Authority: | United States: Federal Government |
Waldenstrom macroglobulinemia stage II grade 3 follicular lymphoma stage II adult diffuse small cleaved cell lymphoma stage II adult diffuse mixed cell lymphoma stage II adult diffuse large cell lymphoma stage II adult immunoblastic large cell lymphoma stage II adult Burkitt lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma |
stage III adult immunoblastic large cell lymphoma stage III adult Burkitt lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult Burkitt lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
Anti-Inflammatory Agents Prednisone Interferon Type I, Recombinant Immunologic Factors Hormone Antagonists Lymphoma, Mantle-Cell Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Mantle Cell Lymphoma Cyclophosphamide Hormones Follicular Lymphoma Lymphoma, Large-cell, Immunoblastic Antibodies, Monoclonal Lymphoma, Small Cleaved-cell, Diffuse |
Lymphoma, B-Cell Anti-Bacterial Agents Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-cell Alkylating Agents Lymphoma Immunoglobulins Interferon-alpha Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Antineoplastic Agents, Hormonal Rituximab Interferons Vincristine Antimitotic Agents |
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Interferon Type I, Recombinant Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |
Alkylating Agents Lymphoma Interferon-alpha Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Growth Substances Mitosis Modulators Interferons Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents |