NCT00002940

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 1996

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1996

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

November 24, 2003

Completed
Last Updated

October 19, 2012

Status Verified

June 1, 2002

Enrollment Period

5.4 years

First QC Date

November 1, 1999

Last Update Submit

October 18, 2012

Conditions

Lymphoma

Keywords

AIDS-related primary CNS lymphoma

Interventions

hydroxyureaDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Related Links

MeSH Terms

Conditions

Lymphoma

Interventions

Hydroxyurea

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic Chemicals

Study Officials

  • Karen S. Slobod, MD

    St. Jude Children's Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

November 24, 2003

Study Start

October 1, 1996

Primary Completion

March 1, 2002

Study Completion

March 1, 2002

Last Updated

October 19, 2012

Record last verified: 2002-06

Locations

US(2)