Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma

• Status: Completed
• Trial end date: 1998-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To estimate the response rate, overall and disease-free survival, toxicities, factors associated with outcome, and effect on quality of life in patients with AIDS-related primary CNS lymphoma treated with CHOD (cyclophosphamide, doxorubicin, vincristine, and dexamethasone) plus filgrastim (granulocyte-colony stimulating factor; G-CSF) and external beam irradiation. To determine other clinical markers present in this patient population.

Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria

Concurrent Medication: Required:

• PCP prophylaxis with Bactrim, dapsone, or aerosolized pentamidine.

• Oral candidiasis prophylaxis with fluconazole, ketoconazole, or clotrimazole oral troches.

• Antiretroviral agent available by therapy IND.

• MAI prophylaxis with rifabutin (in patients with CD4 counts < 100 cells/mm3).

Patients must have:

• HIV infection.

• Primary CNS lymphoma with NO systemic involvement.

Prior Medication:

Allowed:

• Prior corticosteroids.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Concomitant malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin.

• Active uncontrolled infection.

• Renal failure, active nonmalignant duodenal ulcer, uncontrolled diabetes mellitus, or other serious medical conditions that would preclude aggressive cytotoxic chemotherapy administration.

• Active heart disease (congestive heart failure or heart block greater than first degree on EKG).

Concurrent Medication:

Excluded:

• Any investigational agent other than antiretroviral agents available by therapy IND.

Patients with the following prior conditions are excluded:

• No prior malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous cell or basal cell carcinoma of the skin.

• No new infectious complications within the past 2 weeks that require a change in antibiotics.

• History of myocardial infarction within the past 3 months.

Prior Medication:

Excluded:

• Prior chemotherapy other than for Kaposi's sarcoma.