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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000703 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Lymphoma, Non-Hodgkin HIV Infections |
Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride Drug: Cyclophosphamide Drug: Allopurinol Drug: Methotrexate Drug: Cytarabine Drug: Leucovorin calcium Drug: Zidovudine Drug: Dexamethasone |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members |
| Estimated Enrollment: | 45 |
| Primary Completion Date: | March 1990 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 19 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
The following patients will be excluded from the study:
Concurrent Medication:
Excluded:
The following patients will be excluded from the study:
Prior Medication:
Excluded:
Patients must demonstrate the following clinical and laboratory findings:
Contacts and Locations| United States, California | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| United States, District of Columbia | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Louisiana | |
| Charity Hosp / Tulane Univ Med School | |
| New Orleans, Louisiana, United States, 70112 | |
| Louisiana State Univ Med Ctr / Tulane Med School | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane Univ School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Univ of Massachusetts Med Ctr | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, New York | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10025 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Pennsylvania | |
| Milton S Hershey Med Ctr | |
| Hershey, Pennsylvania, United States, 170330850 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| Study Chair: | Levine A |
More Information
| ClinicalTrials.gov Identifier: | NCT00000703 History of Changes |
| Other Study ID Numbers: | ACTG 008 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 11, 2011 |
| Health Authority: | United States: Federal Government |
|
Vincristine Lymphoma Methotrexate Cyclophosphamide Cytarabine Dexamethasone Doxorubicin |
Drug Therapy, Combination Combined Modality Therapy Acquired Immunodeficiency Syndrome Antineoplastic Agents, Combined Zidovudine Bleomycin |
|
HIV Infections Acquired Immunodeficiency Syndrome Lymphoma Lymphoma, Non-Hodgkin Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Allopurinol BB 1101 Methotrexate Zidovudine Cytarabine Cyclophosphamide Antineoplastic Agents Bleomycin Dexamethasone Doxorubicin Vincristine Dexamethasone acetate |
