Metastatic Cancer Clinical Trial
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
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.
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.
;
Primary Purpose: Treatment
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