Lymphoma Clinical Trial
Official title:
Hydroxyurea Treatment of EBV-Associated Primary CNS Lymphoma in Children and Adults With AIDS
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients with
Epstein-Barr virus-associated primary CNS lymphoma and AIDS.
OBJECTIVES: I. Estimate the objective response rate of PCNSL in AIDS patients treated with
hydroxyurea. II. Investigate whether levels of Epstein-Barr virus (EBV) DNA in the blood or
cerebral spinal fluid are correlates of PCNSL disease activity.
OUTLINE: This is an open label pilot study. Patients receive oral hydroxyurea tid. A course
of hydroxyurea consists of 4 weeks of therapy. On day 28, after the first course of
treatment, tumor size is analyzed by MRI. If no reduction in tumor size is seen on day 28,
hydroxyurea dose is increased. If a CR or PR is demonstrated, patients continue on the same
treatment at the original dose. MRI evaluation is again taken on day 56 of treatment.
Patients with progressive disease at this evaluation are considered to have no treatment
response.
PROJECTED ACCRUAL: 15-25 patients will be enrolled. Approximately 8-10 patients will be
accrued annually.
;
Primary Purpose: Treatment
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