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Phase III Randomized Study of CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) With or Without Rituximab in Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma
Alternate Title Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma
Objectives I. Compare the efficacy of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with or without rituximab in patients with previously untreated HIV-associated non-Hodgkin's lymphoma. II. Determine the efficacy of rituximab as maintenance therapy following remission induction with CHOP in these patients. III. Determine the effect of rituximab on the immune system and HIV viral load in these patients. IV. Determine the relationship between EBV load and the presence of EBV in lymphoma tumor cells of these patients. V. Compare the effect of CHOP with or without rituximab on EBV load in these patients. Entry Criteria Disease Characteristics: Histologically or cytologically proven HIV-associated B cell non-Hodgkin's lymphoma, including: Diffuse large B cell lymphoma Intermediate grade diffuse large cell lymphoma High grade large cell immunoblastic lymphoma Burkitt's lymphoma High grade B cell lymphoma, Burkitt's like (small noncleaved lymphoma) No primary CNS lymphoma (parenchymal brain or spinal cord tumor) Evaluable disease HIV documentation may be serologic (ELISA or western blot), culture, or quantitative PCR or bDNA assay Tumors must be CD20 positive (greater than 50% cells express CD20) A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. Prior/Concurrent Therapy: Biologic therapy: Prior or concurrent epoetin alfa or filgrastim (G-CSF) allowed No prior colony stimulating factor therapy within 24 hours prior to chemotherapy Chemotherapy: No prior chemotherapy for HIV-associated non-Hodgkin's lymphoma At least 1 year since prior cyclophosphamide or doxorubicin Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for HIV-associated non-Hodgkin's lymphoma Surgery: Not specified Other: Chronic therapy with myelosuppressive agents allowed Concurrent antiretroviral therapy, antifungal medications, and antibiotics allowed Patient Characteristics: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm3* Platelet count greater than 75,000/mm3* * Unless cytopenias are secondary to lymphoma Hepatic: Bilirubin less than 2.0 mg/dL (unless secondary to hepatic infiltration with lymphoma or isolated hyperbilirubinemia associated with the use of indinavir) SGOT or SGPT less than 7 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL (unless due to lymphoma) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No acute, active HIV-associated opportunistic infection requiring antibiotics Mycobacterium avium complex allowed No concurrent malignancy except carcinoma in situ of the cervix, nonmetastatic nonmelanomatous skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy Expected Enrollment A total of 120 patients will be accrued for this study within 2 years. Outline This is a randomized, multicenter study. Patients are stratified by extent of disease (stage I/II vs III/IV). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 3 and oral prednisone on days 3-7. Patients receive rituximab on day 1. Treatment repeats every 3 weeks for a minimum of 4 courses or 2 courses beyond complete response in the absence of disease progression or unacceptable toxicity. Patients with stage I, stage IE (including bulky), or nonbulky stage II or IIE disease receive 3 courses of chemotherapy with rituximab followed by radiotherapy beginning 3 weeks after completion of the third course. Patients who achieve partial response for a minimum of 28 days or complete response receive maintenance rituximab IV beginning on day 28 of the final course of chemotherapy. Maintenance rituximab treatment repeats every 4 weeks for 3 courses. Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for a minimum of 4 courses or 2 courses beyond complete response. Patients with stage I, stage IE (including bulky), or nonbulky stage II or IIE disease receive 3 courses of chemotherapy. Patients receive radiotherapy beginning 3 weeks after completion of the third course of chemotherapy. Both arms: Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing through day 13 of each chemotherapy course or until blood counts recover. Patients are followed every 4 weeks for 1 year and then every 2 months until death.Published Results Chen X, Cesarman E, Hyjek E, et al.: FOXP1 expression in AIDS-associated diffuse large B-cell lymphoma (DLBCL): correlation with prognostic parameters in patients from AIDS Malignancies Consortium Trial 010. [Abstract] United States and Canadian Academy of Pathology 95th Annual Meeting, February 11-17, 2006, Atlanta, GA. A-1016, 2006. Kaplan LD, Lee JY, Ambinder RF, et al.: Rituximab does not improve clinical outcome in a randomized phase 3 trial of CHOP with or without rituximab in patients with HIV-associated non-Hodgkin lymphoma: AIDS-Malignancies Consortium Trial 010. Blood 106 (5): 1538-43, 2005.[PUBMED Abstract] Related PublicationsChadburn A, Chen X, Chiu A, et al.: Neither germinal center (GC) vs non-germinal center (Non-GC) phenotype nor FOXP1 expression correlate with outcome in AIDS-associated diffuse large B-cell lymphoma (DLBCL): study of patients from AIDS Malignancies Consortium trials 010 and 034. [Abstract] Blood 108 (11): A-2023, 2006. Trial Lead Organizations AIDS Associated Malignancies Clinical Trials Consortium
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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