Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085540
Status:
COMPLETED
Last Update Posted:
2017-01-02
First Post:
2004-06-10
Brief Title:
FR901228 in Treating Patients With Recurrent High-Grade Gliomas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I-II Trial of Depsipeptide in Patients With Recurrent High-Grade Gliomas
Status:
COMPLETED
Status Verified Date:
2016-11
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:
This phase III trial is studying the side effects and best dose of FR901228 and to see how well it works in treating patients with recurrent high-grade gliomas FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD of FR901228 depsipeptide in patients with recurrent malignant gliomas who are taking enzyme-inducing antiepileptic drugs EIAEDs Phase I II Determine the safety profile of this drug in these patients Phase I III Determine the pharmacokinetics and pharmacodynamics of this drug in these patients Phase I IV Determine the clinical efficacy of this drug as measured by 6-month progression-free survival and objective tumor response in these patients Phase II V Determine the safety profile of this drug when administered at the phase I MTD concurrently with or without EIAEDs in these patients Phase II
OUTLINE This is a multicenter phase I dose-escalation study followed by a phase II study Patients are stratified according to study phase I vs II concurrent use of enzyme-inducing anti-epileptic drugs EIAEDs yes vs no histology recurrent glioblastoma multiformegliosarcoma vs recurrent anaplastic glioma pre-operative candidacy yes vs no and measurableevaluable disease yes vs no Patients are assigned to 1 of 2 treatment groups group A no EIAEDs or group B concurrent use of EIAEDs
Phase I group B only Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of FR901228 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose-limiting toxicity
Phase II groups A and B
Group A phase II Patients receive FR901228 as in phase I at dose level 1 Group B phase II Patients receive FR901228 as in phase I at the MTD
I Determine the maximum tolerated dose MTD of FR901228 depsipeptide in patients with recurrent malignant gliomas who are taking enzyme-inducing antiepileptic drugs EIAEDs Phase I II Determine the safety profile of this drug in these patients Phase I III Determine the pharmacokinetics and pharmacodynamics of this drug in these patients Phase I IV Determine the clinical efficacy of this drug as measured by 6-month progression-free survival and objective tumor response in these patients Phase II V Determine the safety profile of this drug when administered at the phase I MTD concurrently with or without EIAEDs in these patients Phase II
OUTLINE This is a multicenter phase I dose-escalation study followed by a phase II study Patients are stratified according to study phase I vs II concurrent use of enzyme-inducing anti-epileptic drugs EIAEDs yes vs no histology recurrent glioblastoma multiformegliosarcoma vs recurrent anaplastic glioma pre-operative candidacy yes vs no and measurableevaluable disease yes vs no Patients are assigned to 1 of 2 treatment groups group A no EIAEDs or group B concurrent use of EIAEDs
Phase I group B only Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of FR901228 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose-limiting toxicity
Phase II groups A and B
Group A phase II Patients receive FR901228 as in phase I at dose level 1 Group B phase II Patients receive FR901228 as in phase I at the MTD
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 |
|---|---|---|---|
| CDR0000370817 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062399 |
| NABTC-0303 | None | None | None |
| U01CA062399 | NIH | None | None |