Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006656
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2000-12-06
Brief Title:
Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
Sponsor:
Direct Therapeutics
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme
Status:
UNKNOWN
Status Verified Date:
2003-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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
PURPOSE Phase II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of intratumoral carmustine in ethanol DTI-015 in patients with unresectable recurrent glioblastoma multiforme Phase I of this study closed to accrual as of 01152002
Determine the qualitative and quantitative toxicity of this regimen in these patients
Assess the activity of this regimen in these patients
Estimate peripheral blood carmustine levels in these patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Patients receive carmustine in ethanol DTI-015 intratumorally over 5 minutes during stereotactic biopsy or open craniotomy
Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity Phase I of this study closed to accrual as of 01152002
Additional patients then receive treatment with DTI-015 at the recommended phase II dose
Patients are followed at 4 8 and 12 weeks and then every 1-3 months until disease progression
PROJECTED ACCRUAL A total of 12 patients were accrued for phase I of this study and approximately 14-18 patients will be accrued for phase II of this study Phase I of this study closed to accrual as of 01152002
Determine the maximum tolerated dose of intratumoral carmustine in ethanol DTI-015 in patients with unresectable recurrent glioblastoma multiforme Phase I of this study closed to accrual as of 01152002
Determine the qualitative and quantitative toxicity of this regimen in these patients
Assess the activity of this regimen in these patients
Estimate peripheral blood carmustine levels in these patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Patients receive carmustine in ethanol DTI-015 intratumorally over 5 minutes during stereotactic biopsy or open craniotomy
Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity Phase I of this study closed to accrual as of 01152002
Additional patients then receive treatment with DTI-015 at the recommended phase II dose
Patients are followed at 4 8 and 12 weeks and then every 1-3 months until disease progression
PROJECTED ACCRUAL A total of 12 patients were accrued for phase I of this study and approximately 14-18 patients will be accrued for phase II of this study Phase I of this study closed to accrual as of 01152002
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 |
|---|---|---|---|
| NCI-V00-1623 | None | None | None |
| DTI-9901 | None | None | None |
| UCMC-00042402 | None | None | None |