Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
NCT ID: NCT00000703
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
1990-03-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Bleomycin sulfate
Vincristine sulfate
Doxorubicin hydrochloride
Cyclophosphamide
Allopurinol
Methotrexate
Cytarabine
Leucovorin calcium
Zidovudine
Dexamethasone
Eligibility Criteria
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Inclusion Criteria
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
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.
19 Years
69 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Levine A
Role: STUDY_CHAIR
Locations
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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 D.C., 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
Countries
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References
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Saag MS, Emini EA, Laskin OL, Douglas J, Lapidus WI, Schleif WA, Whitley RJ, Hildebrand C, Byrnes VW, Kappes JC, et al. A short-term clinical evaluation of L-697,661, a non-nucleoside inhibitor of HIV-1 reverse transcriptase. L-697,661 Working Group. N Engl J Med. 1993 Oct 7;329(15):1065-72. doi: 10.1056/NEJM199310073291502.
Levine AM, Wernz JC, Kaplan L, Rodman N, Cohen P, Metroka C, Bennett JM, Rarick MU, Walsh C, Kahn J, et al. Low-dose chemotherapy with central nervous system prophylaxis and zidovudine maintenance in AIDS-related lymphoma. A prospective multi-institutional trial. JAMA. 1991 Jul 3;266(1):84-8.
ICDB/89653727. Levine AM, et al. Low dose chemotherapy with CNS prophylaxis and zidovudine (AZT) maintenance for aids-related lymphoma: preliminary results of a multi-institutional study. Proc Annu Meet Am Soc Clin Oncol. 1989 8:A18
Other Identifiers
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10984
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 008
Identifier Type: -
Identifier Source: org_study_id