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Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma Clinical research trials and Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma clinical trial. Test subjects typically receive the most expert healthcare available for their Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma  Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma
For Condition: AIDS-related small noncleaved cell lymphoma,AIDS-related immunoblastic large cell lymphoma,Burkitt's Lymphoma,AIDS-related peripheral/systemic lymphoma,AIDS-related diffuse large cell lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , AIDS Associated Malignancies Clinical Trials Consortium
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy plus monoclonal antibody therapy is more effective than combination chemotherapy alone in treating HIV -associated non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have previously untreated HIV-associated non-Hodgkin's lymphoma.
Details: 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. PROTOCOL 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. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LawrenceKaplan, Study Chair, AIDS Associated Malignancies Clinical Trials Consortium
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
San Francisco General Hospital Medical Center
San Francisco, California, 94110
United States
University Hospital/New Jersey Cancer Center
Newark, New Jersey, 07103
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2617
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: CDR0000066666; AMC-010,CPMC-IRB-9691,CWRU-AMC-1400,UCLA-9810029
Study Start Date: January 1999
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003595
Other Aids-Related Small Noncleaved Cell Lymphoma Studies:
1. Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma or High-Risk Stage I Non-Hodgkin's Lymphoma
2. Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma
3. Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
4. Bryostatin 1 Plus Vincristine in Treating Patients With Recurrent or Refractory HIV-Related Lymphoma
5. Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
Related Studies:
Other AIDS-related small noncleaved cell lymphoma Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma
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