Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005855
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2000-06-02
Brief Title:
Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma
Sponsor:
New Approaches to Brain Tumor Therapy Consortium
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study to Evaluate the Safety and Tolerance of Escalating Doses of RSR13 Administered With a Fixed Dose of BCNU Every Six Weeks in Patients With Recurrent Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2003-12
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 Combining more than one drug may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of efaproxiral when given with carmustine and to see how well they work in treating patients with progressive or recurrent malignant glioma
PURPOSE This phase III trial is studying the side effects and best dose of efaproxiral when given with carmustine and to see how well they work in treating patients with progressive or recurrent malignant glioma
Detailed Description:
OBJECTIVES
Evaluate the safety and tolerability of escalating doses of efaproxiral RSR13 when administered concurrently with carmustine in patients with progressive or recurrent malignant glioma
Determine the maximum tolerated dose MTD of RSR13 when administered with carmustine in this patient population
Determine the pharmacokinetic profile of this regimen in these patients
Estimate the efficacy of this regimen at the MTD in these patients
OUTLINE This is a nonrandomized open-label multicenter dose-escalation study of efaproxiral RSR13
Patients receive RSR13 IV over 30 minutes followed 30 minutes later by carmustine IV over 1-2 hours on day 1 Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 6-12 patients receive escalating doses of RSR13 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 or 5 of 12 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to receive treatment with RSR13 and carmustine at the recommended phase II dose
Patients are followed at 6 weeks and then every 2 months thereafter
PROJECTED ACCRUAL A maximum of 48 patients will be accrued for the phase I portion of this study A maximum of 47 patients will be accrued for the phase II portion of this study
Evaluate the safety and tolerability of escalating doses of efaproxiral RSR13 when administered concurrently with carmustine in patients with progressive or recurrent malignant glioma
Determine the maximum tolerated dose MTD of RSR13 when administered with carmustine in this patient population
Determine the pharmacokinetic profile of this regimen in these patients
Estimate the efficacy of this regimen at the MTD in these patients
OUTLINE This is a nonrandomized open-label multicenter dose-escalation study of efaproxiral RSR13
Patients receive RSR13 IV over 30 minutes followed 30 minutes later by carmustine IV over 1-2 hours on day 1 Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 6-12 patients receive escalating doses of RSR13 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 or 5 of 12 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to receive treatment with RSR13 and carmustine at the recommended phase II dose
Patients are followed at 6 weeks and then every 2 months thereafter
PROJECTED ACCRUAL A maximum of 48 patients will be accrued for the phase I portion of this study A maximum of 47 patients will be accrued for the phase II portion of this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JHOC-NABTT-9806 | None | None | None |
| NABTT-9806 | None | None | None |