Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009854
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2001-02-02
Brief Title:
Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
Sponsor:
Direct Therapeutics
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of Intratumoral Injection of DTI-015 Prior to Tumor Resection in Patients With Recurrent Malignant Glioma or Metastatic Neoplasm to Brain
Status:
UNKNOWN
Status Verified Date:
2003-03
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 III trial to study the effectiveness of carmustine followed by surgery in treating patients who have recurrent supratentorial malignant glioma or metastatic brain neoplasm
PURPOSE Phase III trial to study the effectiveness of carmustine followed by surgery in treating patients who have recurrent supratentorial malignant glioma or metastatic brain neoplasm
Detailed Description:
OBJECTIVES
Determine the extent and pattern of distribution of DNA adducts in patients with recurrent supratentorial malignant glioma or metastatic neoplasm to the brain treated with neoadjuvant intratumoral carmustine in ethanol DTI-015 followed by tumor resection
Determine the qualitative and quantitative toxicity of this treatment regimen in these patients
OUTLINE This is a dose escalation study
Patients receive neoadjuvant carmustine in ethanol DTI-015 intratumorally under stereotactic guidance 45-90 minutes prior to craniotomy and tumor resection
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 3 or 3 of 6 patients experience dose-limiting toxicity
Patients are followed at 4 8 and 12 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
Determine the extent and pattern of distribution of DNA adducts in patients with recurrent supratentorial malignant glioma or metastatic neoplasm to the brain treated with neoadjuvant intratumoral carmustine in ethanol DTI-015 followed by tumor resection
Determine the qualitative and quantitative toxicity of this treatment regimen in these patients
OUTLINE This is a dose escalation study
Patients receive neoadjuvant carmustine in ethanol DTI-015 intratumorally under stereotactic guidance 45-90 minutes prior to craniotomy and tumor resection
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 3 or 3 of 6 patients experience dose-limiting toxicity
Patients are followed at 4 8 and 12 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 15 patients will be accrued for 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 |
|---|---|---|---|
| NCI-V00-1642 | None | None | None |
| DTI-0002 | None | None | None |
| UCSF-H7858-17520-01 | None | None | None |