Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003775
Status:
COMPLETED
Last Update Posted:
2012-09-13
First Post:
1999-11-01
Brief Title:
Leflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase II Open Label Study of SU101 for Patients With Anaplastic Astrocytoma in First Relapse
Status:
COMPLETED
Status Verified Date:
2012-09
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 leflunomide in treating patients who have anaplastic astrocytoma in first relapse
PURPOSE Phase II trial to study the effectiveness of leflunomide in treating patients who have anaplastic astrocytoma in first relapse
Detailed Description:
OBJECTIVES I Determine the median time to progression median survival and objective response of patients with anaplastic astrocytoma or anaplastic oligoastrocytoma in first relapse treated with intravenous leflunomide SU101 II Assess the safety of SU101 in these patients III Describe the health-related quality of life of patients treated with intravenous SU101
OUTLINE This is an open label multicenter study Patients receive leflunomide SU101 IV over 6 hours on days 1-4 Patients then receive SU101 IV over 6 hours weekly for 6 weeks beginning between days 8-12 Patients exhibiting complete response partial response or stable disease may continue on treatment for up to a year or until disease progression or unacceptable toxicity occurs Patients continuing therapy receive SU101 IV over 6 hours every week for 7 weeks followed by 1 week of rest Quality of life is assessed every 8 weeks and at the end of the study Patients are followed every 8 weeks or until tumor progression
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
OUTLINE This is an open label multicenter study Patients receive leflunomide SU101 IV over 6 hours on days 1-4 Patients then receive SU101 IV over 6 hours weekly for 6 weeks beginning between days 8-12 Patients exhibiting complete response partial response or stable disease may continue on treatment for up to a year or until disease progression or unacceptable toxicity occurs Patients continuing therapy receive SU101 IV over 6 hours every week for 7 weeks followed by 1 week of rest Quality of life is assessed every 8 weeks and at the end of the study Patients are followed every 8 weeks or until tumor progression
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
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-G99-1506 | None | None | None |
| CDR0000066904 | None | None | None |
| MSKCC-98111 | None | None | None |