Clinical Trials Directory

Trials / Unknown

UnknownNCT00009854

Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm

Phase I/II Study of Intratumoral Injection of DTI-015 Prior to Tumor Resection in Patients With Recurrent Malignant Glioma or Metastatic Neoplasm to Brain

Status
Unknown
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
—
Sponsor
Direct Therapeutics · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II 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.

Conditions

Interventions

TypeNameDescription
DRUGcarmustine in ethanol
PROCEDUREconventional surgery

Timeline

Start date
2000-06-01
First posted
2003-01-27
Last updated
2013-11-06

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00009854. Inclusion in this directory is not an endorsement.