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
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:
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.
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent supratentorial malignant glioma with clear evidence of progression by MRI
Metastatic tumor to the brain other than melanoma
Planned resection of tumor (must be first surgery for recurrent disease)
Tumor volume of each tumor component or residual tumor must be at least 4 cm3 and no greater than 33.4 cm3
Tumor shape and surrounding structure(s) unlikely to cause an irregular distribution of the injected study drug
No tumors in the following locations of the brain:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other: