Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme
NCT ID: NCT00014300
Last Updated: 2012-09-24
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
PHASE2
32 participants
INTERVENTIONAL
2001-01-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of glufosfamide in treating patients who have recurrent glioblastoma multiforme.
Detailed Description
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OUTLINE: This is a multicenter study. Patients receive glufosfamide IV over 60 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease receive treatment for a minimum of 6 months or until progression. Patients with an objective complete response receive a maximum of 2 additional courses of treatment after confirmation of response. Patients are followed every 6 weeks until progression.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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glufosfamide
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN AST and ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: Cardiac function normal No history of ischemic heart disease within the past 6 months 12 lead ECG normal Other: No other prior or concurrent malignancy except cone biopsied cervical cancer or adequately treated basal cell or squamous cell skin cancer No unstable systemic disease No active uncontrolled infection No psychological, familial, sociological, or geographical condition that would preclude study Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic growth factors (e.g., filgrastim (G-CSF)) Chemotherapy: No more than 1 prior chemotherapy regimen as adjuvant therapy or for recurrent disease At least 6 weeks since prior chemotherapy Endocrine therapy: Stable or decreasing dose of corticosteroids for at least 1 week prior to study Radiotherapy: At least 3 months since prior radiotherapy to the brain No prior high-dose radiotherapy (more than 65 Gy), stereotactic radiosurgery, or internal radiotherapy unless the disease recurrence is histologically confirmed Surgery: No prior surgery (except biopsy) for recurrent brain tumor At least 3 months since prior surgery for primary brain tumor Other: No other concurrent anticancer agents No other concurrent investigational agents
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Martin J. van Den Bent, MD
Role: STUDY_CHAIR
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Locations
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Kaiser Franz Josef Hospital
Vienna (Wien), , Austria
Centre Jean Perrin
Clermont-Ferrand, , France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, , France
Centre Leon Berard
Lyon, , France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , France
Centre Antoine Lacassagne
Nice, , France
CHU Pitie-Salpetriere
Paris, , France
Centre Eugene Marquis
Rennes, , France
Institut Gustave Roussy
Villejuif, , France
University of Ioannina
Ioannina, , Greece
Schneider Children's Medical Center of Israel
Petah Tikva, , Israel
Azienda Ospedaliera di Padova
Padova (Padua), , Italy
Istituti Fisioterapici Ospitalieri - Roma
Rome, , Italy
Rotterdam Cancer Institute
Rotterdam, , Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , Netherlands
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, , Portugal
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, , Switzerland
Countries
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Other Identifiers
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EORTC-16994G-26002
Identifier Type: -
Identifier Source: secondary_id
EORTC-16994G-26002
Identifier Type: -
Identifier Source: org_study_id