Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS
- Conditions
- Lymphoma
- Registration Number
- NCT00002940
- Lead Sponsor
- St. Jude Children's Research Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Saint Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States