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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000703
Other study ID # ACTG 008
Secondary ID 10984
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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
Est. primary completion date
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.

Study Design


Related Conditions & MeSH terms


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

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