Karenitecin in Treating Patients With Recurrent Malignant Glioma
NCT ID: NCT00014521
Last Updated: 2008-07-24
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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COMPLETED
PHASE1
INTERVENTIONAL
2002-01-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of karenitecin in treating patients who have recurrent malignant glioma.
Detailed Description
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* Determine the maximum tolerated dose of karenitecin in patients with recurrent malignant glioma who are receiving or not receiving anticonvulsants known to be metabolized by the P450 hepatic enzyme complex.
* Determine the pharmacokinetics of this drug in these patients.
* Assess the preliminary evidence of therapeutic activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to use of anticonvulsants known to be metabolized by the P450 hepatic enzyme complex (yes vs no).
Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of karenitecin according to the continual reassessment method until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose associated with a dose-limiting toxicity rate of 33%.
Patients are followed every 2 months.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study within 1 year.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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karenitecin
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme
* Progressive or recurrent disease previously treated with radiotherapy with or without chemotherapy
* Prior low-grade disease that progressed to high-grade after therapy allowed
* Measurable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
* 18 and over
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/mm3
* Hemoglobin at least 8.5 g/dL
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* Transaminases no greater than 4 times upper limit of normal
Renal:
* Creatinine no greater than 1.7 mg/dL
Other:
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
* No serious concurrent infection
* No other medical illness that would preclude study
* Negative pregnancy test
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* No more than 1 prior chemotherapy regimen
Endocrine therapy:
* Must be on stable dose of steroids for at least 5 days
Radiotherapy:
* See Disease Characteristics
* At least 3 months since prior radiotherapy and recovered
* No more than 1 prior course of radiotherapy
Surgery:
* Not specified
Other:
* No other concurrent investigational agents
* At least 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Principal Investigators
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Stuart A. Grossman, MD
Role: STUDY_CHAIR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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NABTT-2006
Identifier Type: -
Identifier Source: secondary_id
JHOC-NABTT-2006
Identifier Type: -
Identifier Source: secondary_id
CDR0000068552
Identifier Type: -
Identifier Source: org_study_id