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

Completed · Phase 2

Conditions studied: Lymphoma, Non-Hodgkin, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000801

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

33

Expected to finish

1998-04-01

Last updated by the study team

2012-11-01

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• San Francisco AIDS Clinic / San Francisco Gen Hosp — San Francisco, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
• ECOG Data Management Office — Brookline, Massachusetts, United States
• Mount Sinai Med Ctr — New York, New York, United States
• Julio Arroyo — West Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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