Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006080
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2000-08-03
Brief Title:
Fenretinide in Treating Patients With Recurrent Malignant Glioma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase II Evaluation of Fenretinide NSC 374551 as a Single Agent in the Treatment of Adult Patients With Recurrent Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2018-06
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 fenretinide in treating patients who have recurrent malignant glioma
PURPOSE Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent malignant glioma
Detailed Description:
OBJECTIVES I Determine the efficacy of fenretinide as assessed by 6-month progression- free survival in patients with recurrent malignant glioma II Determine the rate of measurable clinical response time to progression and overall survival of patients treated with this drug III Determine the unexpected toxicity of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to disease type glioblastoma multiforme closed to accrual as of 05312001 and gliosarcoma closed to accrual as of 05312001 vs anaplastic astrocytoma anaplastic oligodendroglioma and mixed malignant glioma Patients receive oral fenretinide twice daily during weeks 1 and 4 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and then before each course of chemotherapy Patients are followed every 3 months
PROJECTED ACCRUAL A total of 41-85 patients 21-45 with anaplastic astrocytoma anaplastic oligodendroglioma and mixed malignant glioma and 20-40 with glioblastoma multiforme closed to accrual as of 05312001 and gliosarcoma closed to accrual as of 05312001 will be accrued for this study
OUTLINE This is a multicenter study Patients are stratified according to disease type glioblastoma multiforme closed to accrual as of 05312001 and gliosarcoma closed to accrual as of 05312001 vs anaplastic astrocytoma anaplastic oligodendroglioma and mixed malignant glioma Patients receive oral fenretinide twice daily during weeks 1 and 4 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and then before each course of chemotherapy Patients are followed every 3 months
PROJECTED ACCRUAL A total of 41-85 patients 21-45 with anaplastic astrocytoma anaplastic oligodendroglioma and mixed malignant glioma and 20-40 with glioblastoma multiforme closed to accrual as of 05312001 and gliosarcoma closed to accrual as of 05312001 will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-0006094 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068068 | REGISTRY | None | None |