Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT00006656|
Recruitment Status : Unknown
Verified August 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : November 6, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: carmustine in ethanol Procedure: conventional surgery||Phase 2|
- 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.)
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme|
|Study Start Date :||June 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006656
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90033-0804|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94143-0128|
|Stanford University Medical Center|
|Stanford, California, United States, 94305-5408|
|United States, Colorado|
|University of Colorado Cancer Center|
|Denver, Colorado, United States, 80262|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9416|
|United States, Georgia|
|Emory University Hospital - Atlanta|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Evanston Northwestern Health Care|
|Evanston, Illinois, United States, 60201|
|United States, New Jersey|
|John F. Kennedy Medical Center|
|Edison, New Jersey, United States, 08820|
|United States, Ohio|
|Barrett Cancer Center|
|Cincinnati, Ohio, United States, 45219|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|United States, Virginia|
|Massey Cancer Center|
|Richmond, Virginia, United States, 23298-0631|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Study Chair:||Gene David Resnick, MD||Millennix|