Back to resultsHydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
hydroxyurea
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring AIDS-related primary CNS lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven EBV-associated primary CNS lymphoma HIV infection confirmed by a positive ELISA and Western blot PATIENT CHARACTERISTICS: Age: Open to children and adults of any age Performance Status: Karnofsky at least 50% Life Expectancy: At least 4 weeks Hematopoietic: Hemoglobin at least 6.9 gm/dL ANC at least 500/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 1.5 x upper limit of normal (ULN) (1.5 to 2.5 x ULN if receiving indinavir) Renal: Creatinine no greater than 1.5 x ULN Cardiovascular: Not specified Other: Not pregnant or nursing Contraception required in fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Prior or concurrent antiretroviral therapy allowed No prior EBV-associated primary CNS lymphoma therapy within 1 week of study
Sites / Locations
- Louisiana State University Health Sciences Center - Shreveport
- Saint Jude Children's Research Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002940
First Posted
November 1, 1999
Last Updated
October 18, 2012
Sponsor
St. Jude Children's Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00002940
Brief Title
Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS
Official Title
Hydroxyurea Treatment of EBV-Associated Primary CNS Lymphoma in Children and Adults With AIDS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2002
Overall Recruitment Status
Completed
Study Start Date
October 1996 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
March 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
AIDS-related primary CNS lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
hydroxyurea
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven EBV-associated primary CNS lymphoma HIV infection confirmed by a positive ELISA and Western blot
PATIENT CHARACTERISTICS: Age: Open to children and adults of any age Performance Status: Karnofsky at least 50% Life Expectancy: At least 4 weeks Hematopoietic: Hemoglobin at least 6.9 gm/dL ANC at least 500/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 1.5 x upper limit of normal (ULN) (1.5 to 2.5 x ULN if receiving indinavir) Renal: Creatinine no greater than 1.5 x ULN Cardiovascular: Not specified Other: Not pregnant or nursing Contraception required in fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Prior or concurrent antiretroviral therapy allowed No prior EBV-associated primary CNS lymphoma therapy within 1 week of study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen S. Slobod, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Saint Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105-2794
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital
Learn more about this trial
Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS
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