Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003293
Status:
COMPLETED
Last Update Posted:
2012-09-11
First Post:
1999-11-01
Brief Title:
SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma Multiforme
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase III Randomized Study of SU101 Versus Procarbazine for Patients With Glioblastoma Multiforme 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 It is not yet known whether SU-101 is more effective than procarbazine in treating patients with glioblastoma multiforme
PURPOSE Randomized phase III trial to compare the effectiveness of SU-101 with that of procarbazine in treating patients with glioblastoma multiforme that has recurred
PURPOSE Randomized phase III trial to compare the effectiveness of SU-101 with that of procarbazine in treating patients with glioblastoma multiforme that has recurred
Detailed Description:
OBJECTIVES I Compare the median survival of patients with glioblastoma multiforme in first relapse treated with intravenous leflunomide SU101 administered as a loading dose with weekly maintenance therapy versus oral single-agent procarbazine administered daily for 28 days every 56 days II Compare the median time to progression for these regimens in these patients III Assess the objective response of these patients IV Assess the safety of SU101 given on this schedule V Describe the health-related quality of life of these patients
OUTLINE This is a randomized open label multicenter study Patients are stratified according to performance status Karnofsky 60-80 vs 90-100 age less than 50 vs 50 and over and time from initial diagnosis to recurrence 6 months or greater vs less than 6 months Patients are randomized to one of two treatment arms Arm I Patients receive leflunomide SU101 IV over 6 hours daily on days 1-4 again 4-8 days later and weekly thereafter for a total of 4 loading dose infusions and six maintenance infusions in course 1 Patients receive 7 weekly maintenance infusions of SU101 in courses thereafter Treatment repeats every 8 weeks Arm II Patients receive procarbazine orally once or twice daily for 4 weeks Treatment is repeated every 8 weeks All patients complete a health-related quality-of-life questionnaire every 8 weeks and at study withdrawal Treatment courses continue up to a maximum of 1 year in the absence of unacceptable toxicity or disease progression Patients are followed every 2 months beginning 30 days after study completion
PROJECTED ACCRUAL A maximum of 380 patients will be accrued for this study
OUTLINE This is a randomized open label multicenter study Patients are stratified according to performance status Karnofsky 60-80 vs 90-100 age less than 50 vs 50 and over and time from initial diagnosis to recurrence 6 months or greater vs less than 6 months Patients are randomized to one of two treatment arms Arm I Patients receive leflunomide SU101 IV over 6 hours daily on days 1-4 again 4-8 days later and weekly thereafter for a total of 4 loading dose infusions and six maintenance infusions in course 1 Patients receive 7 weekly maintenance infusions of SU101 in courses thereafter Treatment repeats every 8 weeks Arm II Patients receive procarbazine orally once or twice daily for 4 weeks Treatment is repeated every 8 weeks All patients complete a health-related quality-of-life questionnaire every 8 weeks and at study withdrawal Treatment courses continue up to a maximum of 1 year in the absence of unacceptable toxicity or disease progression Patients are followed every 2 months beginning 30 days after study completion
PROJECTED ACCRUAL A maximum of 380 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 |
|---|---|---|---|
| UCLA-HSPC-980105201 | None | None | None |
| CDR0000066226 | None | None | None |
| MSKCC-98020 | None | None | None |