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Home > "C" Clinical Trials Conditions > Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors  Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors
Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors
For Condition: adult glioblastoma multiforme,adult anaplastic oligodendroglioma,recurrent adult brain tumor,adult anaplastic astrocytoma
Status: Completed
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/II trial to study the effectiveness of irofulven in treating patients who have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme.
Details: OBJECTIVES: - Determine the maximum tolerated dose (MTD) of irofulven alone or combined with anticonvulsants known to be metabolized by cytochrome P450 in patients with progressive or recurrent high-grade anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme. - Assess the pharmacokinetics of this drug on this schedule and determine the effects of P450-inducing anticonvulsants on the pharmacokinetics in these patients. - Determine the response rate of patients treated with this drug administered at the MTD. - Determine the duration of progression-free survival and overall survival of patients treated with this drug. - Determine the toxic effects of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent use of anticonvulsant drugs that induce cytochrome P450 (yes vs no drugs or modest-induction drugs). Patients receive irofulven IV over 30 minutes on days 1-4 or 1-5 (depending on dose-escalation level). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients (per stratum) receive escalating doses of irofulven until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with irofulven at the recommended phase II dose. Patients are followed at 1 week and then every 2 months thereafter. PROJECTED ACCRUAL: Approximately 18 patients (9 per stratum) will be accrued for the phase I portion of the study. Approximately 17-35 patients will be accrued for the phase II portion of the study within 6-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven malignant high-grade glioma that is progressive or recurrent after radiotherapy and/or chemotherapy - Anaplastic astrocytoma - Anaplastic oligodendroglioma - Glioblastoma multiforme - Prior low-grade glioma that has progressed to high-grade glioma after radiotherapy and/or chemotherapy 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/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - Transaminases no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No serious concurrent infection or medical illness that would preclude study therapy - No other prior 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 - Mini mental score at least 15 PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - No more than 2 prior chemotherapy regimens - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: - Maintained on a stable corticosteroid regimen for at least 5 days before and during study Radiotherapy: - See Disease Characteristics - At least 3 months since prior radiotherapy and recovered Surgery: - Recovered from prior surgery Other: - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenRosenfeld, Study Chair, University of Alabama, Birmingham
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1029
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Additional Information:
Study ID Numbers: CDR0000068474; JHOC-NABTT-2005,NABTT-2005
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012038
Other Recurrent Adult Brain Tumor Studies:
1. Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
2. SarCNU in Treating Patients With Recurrent Malignant Glioma
3. BMS 247550 in Treating Patients With Recurrent Glioma
4. High-Dose Methotrexate and Leucovorin Followed By Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
5. Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors
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