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Spots Global Cancer Trial Database for Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members

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Trial Identification

Brief Title: Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members

Official Title: Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members

Study ID: NCT00000703

Study Description

Brief Summary: To determine the safety and effectiveness of a combination chemotherapy-radiation-zidovudine (AZT) treatment for patients with peripheral lymphoma. Other chemotherapies have been tried in patients with AIDS related lymphomas, but the results have not been satisfactory. This study will show whether the combination of chemotherapy, radiation, and AZT is more effective and less toxic than previously used treatments.

Detailed Description: Other chemotherapies have been tried in patients with AIDS related lymphomas, but the results have not been satisfactory. This study will show whether the combination of chemotherapy, radiation, and AZT is more effective and less toxic than previously used treatments. All patients will receive combination chemotherapy and AZT. The combination chemotherapy will be repeated every 3 to 4 weeks for a maximum total of 6 cycles. Each cycle will consist of doxorubicin, bleomycin, cyclophosphamide, and vincristine on day 1, dexamethasone on days 1-5, and methotrexate on day 15. Patients with meningeal or bone marrow disease will receive radiation and intrathecal cytarabine (ARA-C) while those without will receive ARA-C without radiation. Patients with documented lymphomas in the central nervous system at initial workup will start radiation as soon as possible and intrathecal ARA-C (t.i.w. until cerebrospinal fluid is clear then every month for 1 year); patients with normal lumbar puncture, brain scan, and bone marrow at first diagnosis will begin radiation on day 1 of cycle 3 of chemotherapy. Lumbar punctures for evaluation will be done four times during the first cycle, on days 1, 8, 21, and 28. AZT will be administered every 4 hours, 7 days a week, beginning at the completion of combined chemotherapy, once the patient has achieved a complete remission of the lymphoma, and continuing for 1 year.

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Los Angeles County - USC Med Ctr, Los Angeles, California, United States

UCLA CARE Ctr, Los Angeles, California, United States

San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco, California, United States

George Washington Univ Med Ctr, Washington, District of Columbia, United States

Charity Hosp / Tulane Univ Med School, New Orleans, Louisiana, United States

Louisiana State Univ Med Ctr / Tulane Med School, New Orleans, Louisiana, United States

Tulane Univ School of Medicine, New Orleans, Louisiana, United States

Univ of Massachusetts Med Ctr, Worcester, Massachusetts, United States

Bellevue Hosp / New York Univ Med Ctr, New York, New York, United States

Saint Luke's - Roosevelt Hosp Ctr, New York, New York, United States

Mount Sinai Med Ctr, New York, New York, United States

Univ of Rochester Medical Center, Rochester, New York, United States

Milton S Hershey Med Ctr, Hershey, Pennsylvania, United States

Julio Arroyo, West Columbia, South Carolina, United States

Contact Details

Name: Levine A

Affiliation:

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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