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Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma Clinical research trials and Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma. Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma clinical trial. Subjects frequently get the best healthcare possible for their Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma  Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma
Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma
For Condition: AIDS-related diffuse small cleaved cell lymphoma,AIDS-related small noncleaved cell lymphoma,AIDS-related diffuse mixed cell lymphoma,AIDS-related immunoblastic large cell lymphoma,AIDS-related peripheral/systemic lymphoma,AIDS-related diffuse large cell lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Southwest Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Antiviral therapy may be effective treatment for AIDS -related lymphoma. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and antiviral therapy in treating patients who have AIDS-related lymphoma.
Details: OBJECTIVES: I. Assess the response rate of AIDS-related lymphoma to ProMACE-CytaBOM (cyclophosphamide, doxorubicin, etopside, prednisone, cytarabine, bleomycin, vincristine, methotrexate). II. Assess the toxic effects of ProMACE-CytaBOM in patients with AIDS-related lymphoma. III. Evaluate whether the incorporation of filgrastim (G-CSF) into the regimen allows treatment with full doses of the myelotoxic agents in these patients. IV. Determine whether intensive CNS treatment with intrathecal cytarabine and whole-brain irradiation prevents meningeal relapse or controls meningeal lymphomatous involvement in these patients. PROTOCOL OUTLINE: Patients are stratified according to participating institution and descriptive factors: histopathology (diffuse large cleaved/noncleaved and immunoblastic lymphomas vs all others), CD4 count (less than 50 vs 50 or more cells/mm3), prior opportunistic infection (yes vs no), performance status (0 and 1 vs 2), concurrent AZT (yes vs no), concurrent protease inhibitors (yes vs no), marrow involvement (yes vs no). Patients receive ProMACE-CytaBOM regimen as follows: Cyclophosphamide, doxorubicin, and etopside IV on day 1 Cytarabine, bleomycin, vincristine, and methotrexate IV on day 8 Oral prednisone on days 1-14 Oral leucovorin calcium every 6 hours for 4 doses on day 9 Patients also receive filgrastim (G-CSF) subcutaneously on days 9-20 and oral co-trimoxazole 3 days a week throughout treatment, plus antiretroviral therapy at the discretion of the treating physician. Treatment repeats every 21 days for a maximum of 6 courses. Patients with progressive disease are removed from study after 2 courses. Remaining patients receive an additional 2 treatment courses and are then restaged. Patients without stable or progressive disease receive 2 more courses in the absence of unacceptable toxicity. Patients with positive bone marrow at study entry receive CNS prophylaxis with 5 evenly spaced doses of intrathecal cytarabine during the first 2 treatment courses and on day 1 of each subsequent course. Patients with positive CSF cytology at study entry receive intrathecal cytarabine on days 1-5 of the first treatment course and on day 1 of each subsequent course if CSF negative after 5 daily doses. Patients whose CSF remains positive after 5 days receive 5 evenly spaced doses of intrathecal methotrexate during the second treatment course. Patients with negative bone marrow and CSF cytology at study entry receive 5 evenly spaced doses of intrathecal cytarabine within 1 month of systemic therapy. All patients achieving a complete or partial response following systemic therapy and intrathecal cytarabine receive cranial irradiation to all meningeal surfaces. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, then annually thereafter. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over approximately 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven intermediate or high grade non-Hodgkin's lymphoma of one of the following histologies: Follicular, predominantly large cell; Diffuse, small cleaved cell Diffuse mixed, small and large cell; Diffuse, large cell (cleaved or noncleaved); Immunoblastic, large cell Small noncleaved cell, Burkitt's or non-Burkitt's; No lymphoblastic lymphoma - Prior diagnosis of AIDS or HIV positivity required; Confirmation of HIV antibody status by Western blot mandatory - Bidimensionally measurable or evaluable disease - No primary CNS lymphoma - Concurrent registration on protocol SWOG-8947 (central serum repository) required --Prior/Concurrent Therapy-- - No prior chemotherapy or radiotherapy for lymphoma --Patient Characteristics-- - Age: Over 18 - Performance status: SWOG 0-2 - Hematopoietic: Absolute neutrophil count at least 500/mm3; Platelet count at least 75,000/mm3 - Hepatic: AST no greater than 1.5 times normal; Alkaline phosphatase no greater than 1.5 times normal; LDH no greater than 1.5 times normal; PT/PTT normal - Renal: Creatinine no greater than 2.0 times normal; Creatinine clearance at least 60 mL/min - Cardiovascular: No serious abnormalities on EKG; No history of severe coronary artery disease; No history of cardiomyopathy, congestive heart failure, or arrhythmia - Other: No active uncontrolled infection; No active second malignancy within 5 years except adequately treated nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LodeSwinnen, Study Chair, Southwest Oncology Group
Texas Tech University Health Science Center
Lubbock, Texas, 79423
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
Puget Sound Oncology Consortium
Seattle, Washington, 98109
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
United States
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, 85012
United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
CCOP - Dayton
Kettering, Ohio, 45429
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
MBCCOP - University of South Alabama
Mobile, Alabama, 36688
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, 97201-3098
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110-0250
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Cleveland Clinic Cancer Center
Cleveland, Ohio, 44195
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
University of Texas Medical Branch
Galveston, Texas, 77555-1329
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Additional Information:
Study ID Numbers: CDR0000063620; SWOG-9320
Study Start Date: June 1994
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002571
Other Aids-Related Diffuse Mixed Cell Lymphoma Studies:
1. Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
2. Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
3. Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
4. 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
5. Interleukin-12 Following Chemotherapy in Treating Patients With Refractory HIV-Associated Non-Hodgkin's Lymphoma
Related Studies:
Other AIDS-related diffuse mixed cell lymphoma Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma
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