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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000703

Collaborator

(none)

Enrollment

Locations

3.2

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin HIV Infections	Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride Drug: Cyclophosphamide Drug: Allopurinol Drug: Methotrexate Drug: Cytarabine Drug: Leucovorin calcium Drug: Zidovudine Drug: Dexamethasone	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Actual Study Completion Date :

Mar 1, 1990

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Los Angeles County - USC Med Ctr	Los Angeles	California	United States	90033
2	UCLA CARE Ctr	Los Angeles	California	United States	90095
3	San Francisco AIDS Clinic / San Francisco Gen Hosp	San Francisco	California	United States	941102859
4	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
5	Charity Hosp / Tulane Univ Med School	New Orleans	Louisiana	United States	70112
6	Louisiana State Univ Med Ctr / Tulane Med School	New Orleans	Louisiana	United States	70112
7	Tulane Univ School of Medicine	New Orleans	Louisiana	United States	70112
8	Univ of Massachusetts Med Ctr	Worcester	Massachusetts	United States	01655
9	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
10	Saint Luke's - Roosevelt Hosp Ctr	New York	New York	United States	10025
11	Mount Sinai Med Ctr	New York	New York	United States	10029
12	Univ of Rochester Medical Center	Rochester	New York	United States	14642
13	Milton S Hershey Med Ctr	Hershey	Pennsylvania	United States	170330850
14	Julio Arroyo	West Columbia	South Carolina	United States	29169