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	Treatment or 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

Further Study Details: 

Expected Total Enrollment:  45

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.

Ages Eligible for Study:  19 Years   -   69 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

• Ibuprofen.
• Standard antiemetic agents.
• Ganciclovir therapy for sight- or life-threatening Cytomegalovirus infection.
• Zidovudine and methotrexate may be resumed during ganciclovir maintenance phase.

Exclusion Criteria

Co-existing Condition: The following patients will be excluded from the study:

• Patients with recurrent infection that may interfere with the planned protocol.
• Patients with a second active tumor other than nonmelanomatous skin cancer or Kaposi's sarcoma.
• Patients with stage IE primary central nervous system lymphoma. Concurrent Medication: Excluded:
• Corticosteroids.
• Aspirin.
• Acetaminophen.
• Nonsteroidal anti-inflammatory drugs, except ibuprofen.
• Chemotherapy for infection associated with neutropenia.
• Zidovudine (AZT) for infection associated with neutropenia.
• Investigational therapies, except ganciclovir therapy for sight- or life-threatening cytomegalovirus infection.
• AZT and methotrexate will be suspended during induction therapy with ganciclovir.

The following patients will be excluded from the study:

• Patients with recurrent infection that may interfere with the planned protocol.
• Patients with a second active tumor other than nonmelanomatous skin cancer or Kaposi's sarcoma.
• Patients with stage IE primary central nervous system lymphoma. Prior Medication: Excluded:
• Zidovudine (AZT).
• Excluded within 2 weeks of study entry:
• Immunomodulating agents.
• Antiretroviral therapy prior to diagnosis of lymphoma.

Patients must demonstrate the following clinical and laboratory findings:

• Any stage of the disease, including stage I.
• Newly diagnosed, previously untreated high-grade lymphoma.
• Presence of measurable tumor parameter(s).
• Adequate hepatic, renal, and bone marrow function.

California
      San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco,  California,  941102859,  United States
      UCLA CARE Ctr, Los Angeles,  California,  90095,  United States
      Los Angeles County - USC Med Ctr, Los Angeles,  California,  90033,  United States
District of Columbia
      George Washington Univ Med Ctr, Washington,  District of Columbia,  20037,  United States
Louisiana
      Charity Hosp / Tulane Univ Med School, New Orleans,  Louisiana,  70112,  United States
      Louisiana State Univ Med Ctr / Tulane Med School, New Orleans,  Louisiana,  70112,  United States
      Tulane Univ School of Medicine, New Orleans,  Louisiana,  70112,  United States
Massachusetts
      Univ of Massachusetts Med Ctr, Worcester,  Massachusetts,  01655,  United States
New York
      Univ of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
      Saint Luke's - Roosevelt Hosp Ctr, New York,  New York,  10025,  United States
Pennsylvania
      Milton S Hershey Med Ctr, Hershey,  Pennsylvania,  170330850,  United States
South Carolina
      Julio Arroyo, West Columbia,  South Carolina,  29169,  United States

Study chairs or principal investigators

Levine A,  Study Chair

Study ID Numbers:  ACTG 008
Record last reviewed:  December 1988
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000703
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08