Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
19 Years
69 Years
Both
Lymphoma, Non-Hodgkin, HIV Infections
Trial Information
Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
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.
Inclusion 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.
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Levine A
Investigator Role:
Study Chair
Authority:
United States: Federal Government
Study ID:
ACTG 008
NCT ID:
NCT00000703
Start Date:
Completion Date:
March 1990
Related Keywords:
- Lymphoma, Non-Hodgkin
- HIV Infections
- 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
Name | Location |
|---|---|
| Bellevue Hosp / New York Univ Med Ctr | New York, New York 10016 |
| Saint Luke's - Roosevelt Hosp Ctr | New York, New York 10025 |
| Univ of Rochester Medical Center | Rochester, New York 14642 |
| Julio Arroyo | West Columbia, South Carolina 29169 |
| Los Angeles County - USC Med Ctr | Los Angeles, California 90033 |
| UCLA CARE Ctr | Los Angeles, California 90095 |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | San Francisco, California 941102859 |
| George Washington Univ Med Ctr | Washington, District of Columbia 20037 |
| Louisiana State Univ Med Ctr / Tulane Med School | New Orleans, Louisiana 70112 |
| Tulane Univ School of Medicine | New Orleans, Louisiana 70112 |
| Univ of Massachusetts Med Ctr | Worcester, Massachusetts 01655 |
| Mount Sinai Med Ctr | New York, New York 10029 |
| Milton S Hershey Med Ctr | Hershey, Pennsylvania 170330850 |
| Charity Hosp / Tulane Univ Med School | New Orleans, Louisiana 70112 |
