Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075491
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2004-01-09
Brief Title:
Neoadjuvant and Adjuvant Fenretinide Compared With Adjuvant Fenretinide Alone in Treating Patients Who Are Undergoing Surgical Resection For Recurrent Glioblastoma Multiforme
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation With Correlative Studies Of Fenretinide NSC 374551-4HPR As A Single Agent In The Treatment Of Adult Patients With Recurrent Glioblastoma Multiforme
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase II trial is studying how well neoadjuvant and adjuvant fenretinide works compared to adjuvant fenretinide alone in treating patients who are undergoing surgical resection for recurrent glioblastoma multiforme Chemotherapy drugs such as fenretinide work in different ways to stop tumor cells from dividing so they stop growing or die Giving chemotherapy before surgery may shrink the tumor so that it can be removed Giving chemotherapy after surgery may kill any remaining tumor cells It is not yet known whether neoadjuvant and adjuvant fenretinide is more effective than adjuvant fenretinide alone
Detailed Description:
PRIMARY OBJECTIVES
I Compare the efficacy of neoadjuvant and adjuvant fenretinide vs adjuvant fenretinide alone in terms of 6-month progression-free survival in patients with recurrent glioblastoma multiforme undergoing surgical resection II Correlate the serum and glioma tissue pharmacology of this drug with clinical response in patients treated with these regimens
III Determine whether this drug induces apoptosis in glioma tissue in patients treated with these regimens
IV Correlate the apoptotic index with tissue and serum concentration and clinical response in patients treated with these regimens
V Compare radiological response overall survival and unexpected toxicity in patients treated with these regimens
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive neoadjuvant oral fenretinide twice daily for 1 week and then undergo surgical resection
Arm II Patients undergo surgical resection
Beginning two weeks after surgery all patients receive adjuvant oral fenretinide twice daily on weeks 1 and 4 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 21-46 patients 10-23 per treatment arm will be accrued for this study within 7-46 months
I Compare the efficacy of neoadjuvant and adjuvant fenretinide vs adjuvant fenretinide alone in terms of 6-month progression-free survival in patients with recurrent glioblastoma multiforme undergoing surgical resection II Correlate the serum and glioma tissue pharmacology of this drug with clinical response in patients treated with these regimens
III Determine whether this drug induces apoptosis in glioma tissue in patients treated with these regimens
IV Correlate the apoptotic index with tissue and serum concentration and clinical response in patients treated with these regimens
V Compare radiological response overall survival and unexpected toxicity in patients treated with these regimens
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive neoadjuvant oral fenretinide twice daily for 1 week and then undergo surgical resection
Arm II Patients undergo surgical resection
Beginning two weeks after surgery all patients receive adjuvant oral fenretinide twice daily on weeks 1 and 4 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 21-46 patients 10-23 per treatment arm will be accrued for this study within 7-46 months
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 |
|---|---|---|---|
| ID02-701 | None | None | None |
| R21CA097767 | NIH | None | None |
| CDR0000346722 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchR21CA097767 |