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

Completed · Not applicable

Conditions studied: Lymphoma, Non-Hodgkin, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000703

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

45

Expected to finish

1990-03-01

Last updated by the study team

2021-11-03

Who can join

Age: 19 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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