A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme
- Determine the maximum tolerated dose of intratumoral carmustine in ethanol (DTI-015) in
patients with unresectable recurrent glioblastoma multiforme. (Phase I of this study
closed to accrual as of 01/15/2002.)
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Assess the activity of this regimen in these patients.
- Estimate peripheral blood carmustine levels in these patients treated with this
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive carmustine in ethanol (DTI-015) intratumorally over 5 minutes during
stereotactic biopsy or open craniotomy.
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 6 patients
experience dose-limiting toxicity. (Phase I of this study closed to accrual as of
Additional patients then receive treatment with DTI-015 at the recommended phase II dose.
Patients are followed at 4, 8, and 12 weeks and then every 1-3 months until disease
PROJECTED ACCRUAL: A total of 12 patients were accrued for phase I of this study and
approximately 14-18 patients will be accrued for phase II of this study. (Phase I of this
study closed to accrual as of 01/15/2002.)
Primary Purpose: Treatment
Gene David Resnick, MD
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Stanford University Medical Center||Stanford, California 94305-5408|
|University of Colorado Cancer Center||Denver, Colorado 80262|
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Emory University Hospital - Atlanta||Atlanta, Georgia 30322|
|UCSF Cancer Center and Cancer Research Institute||San Francisco, California 94115-0128|
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|John F. Kennedy Medical Center||Edison, New Jersey 08818|
|Massey Cancer Center||Richmond, Virginia 23298-0037|
|Evanston Northwestern Health Care||Evanston, Illinois 60201|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Barrett Cancer Center||Cincinnati, Ohio 45267-0502|