Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
NCT ID: NCT00006656
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
2000-06-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.
Detailed Description
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* 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.)
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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carmustine in ethanol
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* Histologically proven supratentorial malignant glioblastoma multiforme
* Clear evidence of disease progression by MRI
* Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated)
* Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm
* No brainstem (pons or medulla) or midbrain (mesencephalon) involvement
* No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve
* No tumor extension into the ventricular system
* Tumor volume no greater than 33.4 cm3
* At least one prior radiotherapy
PATIENT CHARACTERISTICS:
Age:
* 18 to 75
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No evidence of bleeding diathesis
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* SGOT/SGPT no greater than 2.5 times normal
Renal:
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 40 mL/min
* BUN no greater than 30 mg/dL
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active uncontrolled infection
* Afebrile unless fever due to presence of tumor
* No other concurrent serious medical or psychiatric illness that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* No prior intracranial brachytherapy
Surgery:
* Recovered from any prior surgery
Other:
* No prior anticoagulants
* No other concurrent investigational agents
18 Years
75 Years
ALL
No
Sponsors
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Direct Therapeutics
INDUSTRY
Principal Investigators
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Gene David Resnick, MD
Role: STUDY_CHAIR
Millennix
Locations
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USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Evanston Northwestern Health Care
Evanston, Illinois, United States
John F. Kennedy Medical Center
Edison, New Jersey, United States
Barrett Cancer Center
Cincinnati, Ohio, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Massey Cancer Center
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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DTI-9901
Identifier Type: -
Identifier Source: secondary_id
UCMC-00042402
Identifier Type: -
Identifier Source: secondary_id
NCI-V00-1623
Identifier Type: -
Identifier Source: secondary_id
CDR0000068207
Identifier Type: -
Identifier Source: org_study_id