Status:
COMPLETED
Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Lymphoma, Non-Hodgkin
HIV Infections
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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 ...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 1998
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00000801
End Date
April 1 1998
Last Update
November 1 2012
Active Locations (7)
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1
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
2
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
3
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
4
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215