Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma, Non-Hodgkin; HIV Infections
Intervention: Bleomycin sulfate (Drug); Vincristine sulfate (Drug); Doxorubicin hydrochloride (Drug); Cyclophosphamide (Drug); Allopurinol (Drug); Methotrexate (Drug); Cytarabine (Drug); Leucovorin calcium (Drug); Zidovudine (Drug); Dexamethasone (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Levine A, Study Chair
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.
Clinical Details
Official title: Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
Study design: Treatment
Detailed 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.
Eligibility
Minimum age: 19 Years.
Maximum age: 69 Years.
Gender(s): 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.
Locations and Contacts
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
George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States
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
Univ of Massachusetts Med Ctr, Worcester, Massachusetts 01655, United States
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
Milton S Hershey Med Ctr, Hershey, Pennsylvania 170330850, United States
Julio Arroyo, West Columbia, South Carolina 29169, United States
Additional Information
Click here for more information about Zidovudine
Related publications: 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. 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
Last updated: June 23, 2005
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