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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000703
• Other study ID #: ACTG 008
• Secondary ID: 10984
• Status: Completed
• Phase: N/A
• Est. completion date: March 1990

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 1990
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Bleomycin sulfate

• Vincristine sulfate

• Doxorubicin hydrochloride

• Cyclophosphamide

• Allopurinol

• Methotrexate

• Cytarabine

• Leucovorin calcium

• Zidovudine

• Dexamethasone

Locations

Country	Name	City	State
United States	Milton S Hershey Med Ctr	Hershey	Pennsylvania
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	UCLA CARE Ctr	Los Angeles	California
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	Bellevue Hosp / New York Univ Med Ctr	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York
United States	Univ of Rochester Medical Center	Rochester	New York
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	Julio Arroyo	West Columbia	South Carolina
United States	Univ of Massachusetts Med Ctr	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

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. — View Citation

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. — View Citation