A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme
OBJECTIVES:
- 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
regimen.
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
01/15/2002.)
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
progression.
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.)
Interventional
Primary Purpose: Treatment
Gene David Resnick, MD
Study Chair
Millennix
United States: Federal Government
CDR0000068207
NCT00006656
June 2000
Name | Location |
---|---|
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 |