Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016328
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2001-05-06
Brief Title:
CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Phase II trial to study the effectiveness of CCI-779 in treating patients who have recurrent glioblastoma multiforme Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the efficacy of CCI-779 in terms of the percentage of patients who are progression-free at 6 months time to progression and time to death in patients with recurrent glioblastoma multiforme
II Determine the toxic effects of this drug in these patients III Correlate molecular alterations in the tumors of these patients with response to treatment with this drug
OUTLINE This is a multicenter study Patients are stratified according to concurrent P450 anticonvulsant use yes vs no
Patients receive CCI-779 IV over 30 minutes once weekly for 4 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 5 years and then annually for up to 10 years
PROJECTED ACCRUAL A total of 63 patients will be accrued for this study within 39 months
I Determine the efficacy of CCI-779 in terms of the percentage of patients who are progression-free at 6 months time to progression and time to death in patients with recurrent glioblastoma multiforme
II Determine the toxic effects of this drug in these patients III Correlate molecular alterations in the tumors of these patients with response to treatment with this drug
OUTLINE This is a multicenter study Patients are stratified according to concurrent P450 anticonvulsant use yes vs no
Patients receive CCI-779 IV over 30 minutes once weekly for 4 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 5 years and then annually for up to 10 years
PROJECTED ACCRUAL A total of 63 patients will be accrued for this study within 39 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 |
|---|---|---|---|
| U10CA025224 | NIH | None | httpsreporternihgovquickSearchU10CA025224 |
| N997B | None | None | None |
| CDR0000068623 | None | None | None |
| NCCTG-N997B | None | None | None |