Hydroxyurea |
Droxia; Hydrea |
Clinical Trial: Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS
This study is no longer recruiting patients.
|
Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| AIDS-related primary CNS lymphoma | Procedure: chemotherapy Drug: hydroxyurea | Phase II |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Pilot Study of Hydroxyurea in Patients with EBV-Associated Primary CNS Lymphoma (PCNSL) and AIDS
Study start: October 1996
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.
PROTOCOL 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.
Eligibility
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically proven EBV-associated primary CNS lymphoma
- HIV infection confirmed by a positive ELISA and Western blot
--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
--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
Location Information
Louisiana
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States
Tennessee
Saint Jude Children's Research Hospital, Memphis, Tennessee, 38105-2794, United States
Karen S. Slobod, Study Chair, St. Jude Children's Research Hospital
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: November 2003
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002940
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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