Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors
A Phase I/II Trial Of MGI114 For Treatment Of Patients With Recurrent Malignant Gliomas
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
-
-
Florida
-
Tampa, Florida, Forenede Stater, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Emory University Hospital - Atlanta
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital Cancer Center
-
-
Michigan
-
Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
-
-
North Carolina
-
Winston-Salem, North Carolina, Forenede Stater, 27157-1029
- Comprehensive Cancer Center at Wake Forest University
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
-
-
Texas
-
San Antonio, Texas, Forenede Stater, 78284-7811
- University of Texas Health Science Center at San Antonio
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Steven S. Rosenfeld, MD, PhD, University of Alabama at Birmingham
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000068474
- NABTT-2005
- JHOC-NABTT-2005
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .