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Home > "K" Clinical Trials Conditions > Karenitecin in Treating Patients With Recurrent Malignant Glioma  Karenitecin in Treating Patients With Recurrent Malignant Glioma
Karenitecin in Treating Patients With Recurrent Malignant Glioma
For Condition: adult anaplastic astrocytoma,adult anaplastic oligodendroglioma,recurrent adult brain tumor,adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of karenitecin in treating patients who have recurrentmalignantglioma.
Details: OBJECTIVES: - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StuartGrossman, Study Chair, Sidney Kimmel Cancer Center
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting David Lawson 404-778-4189
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting E. Chiocca 617-726-3779
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Mark Rosenblum 313-916-1340
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1030
United States
Recruiting Edward Shaw 336-716-4647
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Stuart Grossman 410-955-8837
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Steven Brem 813-979-3063
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Kevin Judy 215-662-7854
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Louis Nabors 205-934-1432
Additional Information:
Study ID Numbers: CDR0000068552; NABTT-2006,JHOC-NABTT-2006
Study Start Date:
Record last reviewed: February 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014521
Other Recurrent Adult Brain Tumor Studies:
1. Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
2. Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
3. Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma
4. Etoposide Plus Cisplatin in Treating Patients With Recurrent Ependymomas
5. Combination Chemotherapy in Treating Patients With Recurrent Glioblastoma Multiforme
Related Studies:
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Karenitecin in Treating Patients With Recurrent Malignant Glioma
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