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

• Status: Completed
• Trial end date: 1990-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Allopurinol; BB 1101; Bleomycin; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Leucovorin; Levoleucovorin; Liposomal doxorubicin; Methotrexate; Vincristine; Zidovudine

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.