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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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

Patients who upon staging workup are found to be without systemic involvement undergo one cycle of chemotherapy with cyclophosphamide, doxorubicin, vincristine, dexamethasone, and G-CSF. Cyclophosphamide, doxorubicin, and vincristine are administered intravenously on day 1. Dexamethasone is administered intravenously on day 1 and then orally thereafter with gradual discontinuation. G-CSF is administered subcutaneously daily beginning on day 2 and continuing for a total of 10 days or until bl...

Gender

ALL

Eligibility 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.

Trial Officials