Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS
|ClinicalTrials.gov Identifier: NCT00002940|
Recruitment Status : Completed
First Posted : November 24, 2003
Last Update Posted : October 19, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: hydroxyurea||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Hydroxyurea Treatment of EBV-Associated Primary CNS Lymphoma in Children and Adults With AIDS|
|Study Start Date :||October 1996|
|Actual Primary Completion Date :||March 2002|
|Actual Study Completion Date :||March 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002940
|United States, Louisiana|
|Louisiana State University Health Sciences Center - Shreveport|
|Shreveport, Louisiana, United States, 71130-3932|
|United States, Tennessee|
|Saint Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105-2794|
|Study Chair:||Karen S. Slobod, MD||St. Jude Children's Research Hospital|