Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002940
Status:
COMPLETED
Last Update Posted:
2012-10-19
First Post:
1999-11-01
Brief Title:
Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Hydroxyurea Treatment of EBV-Associated Primary CNS Lymphoma in Children and Adults With AIDS
Status:
COMPLETED
Status Verified Date:
2002-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V97-1143 | OTHER | National Cancer Institute | None |
| SJCRH-DID-965 | OTHER | None | None |