Hydroxyurea Treatment of EBV-Associated Primary CNS Lymphoma in Children and Adults With AIDS


Phase 2
N/A
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Hydroxyurea Treatment of EBV-Associated Primary CNS Lymphoma in Children and Adults With AIDS


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Karen S. Slobod, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000065389

NCT ID:

NCT00002940

Start Date:

October 1996

Completion Date:

March 2002

Related Keywords:

  • Lymphoma
  • AIDS-related primary CNS lymphoma
  • Lymphoma

Name

Location
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Saint Jude Children's Research Hospital Memphis, Tennessee  38105-2794