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Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS



Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS

For Condition: AIDS-related primary CNS lymphoma
Status: No longer recruiting
Sponsor(s): St. Jude Children's Research Hospital ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
KarenSlobod,  Study Chair,  St. Jude Children's Research Hospital

Louisiana State University Health Sciences Center - Shreveport
Shreveport,  Louisiana,  71130-3932
United States
 

Saint Jude Children's Research Hospital
Memphis,  Tennessee,  38105-2794
United States
 


Additional Information:
Study ID Numbers:
  CDR0000065389;  SJCRH-DID-965,NCI-V97-1143
Study Start Date: October 1996
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002940

Other Aids-Related Primary Cns Lymphoma Studies:
1. Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS

2. Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma

3. Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma

4. Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma

Related Studies:

Other AIDS-related primary CNS lymphoma Clinical Trials
Other Louisiana Clinical Trials
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Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS

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