Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006773
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2000-12-06
Brief Title:
Bortezomib in Treating Patients With Recurrent Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Evaluation of the Safety of PS 341 in the Treatment of Recurrent Gliomas
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:
Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of bortezomib with or without anticonvulsant drugs known to be metabolized by the P450 hepatic enzyme complex in patients with recurrent glioma
II Determine the biologic activity of this drug by measuring proteasome 20S activity in these patients
III Determine the effects of hepatic enzyme-inducing drugs such as anticonvulsants on biologic activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to concurrent anticonvulsant drug use phenytoin carbamazepine phenobarbital primidone or felbamate vs gabapentin lamotrigine valproic acid or no anticonvulsant drugs
Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 10 additional patients are treated with bortezomib at the MTD Patients are followed every 2 months
I Determine the maximum tolerated dose of bortezomib with or without anticonvulsant drugs known to be metabolized by the P450 hepatic enzyme complex in patients with recurrent glioma
II Determine the biologic activity of this drug by measuring proteasome 20S activity in these patients
III Determine the effects of hepatic enzyme-inducing drugs such as anticonvulsants on biologic activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to concurrent anticonvulsant drug use phenytoin carbamazepine phenobarbital primidone or felbamate vs gabapentin lamotrigine valproic acid or no anticonvulsant drugs
Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 10 additional patients are treated with bortezomib at the MTD Patients are followed every 2 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 |
|---|---|---|---|
| NABTT-9910 | None | None | None |
| U01CA062475 | NIH | None | None |
| CDR0000068326 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062475 |