Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
Recruitment status was Active, not recruiting
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.
Brain and Central Nervous System Tumors
Drug: carmustine in ethanol
Procedure: conventional surgery
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||June 2000|
- 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.
|United States, California|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94143-0128|
|United States, Virginia|
|Massey Cancer Center|
|Richmond, Virginia, United States, 23298-0631|
|Study Chair:||Gene David Resnick, MD||Millennix|