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Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2001 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on April 10, 2001.   Last Updated on July 23, 2008   History of Changes
Sponsor: European Organization for Research and Treatment of Cancer - EORTC
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00014300
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of glufosfamide in treating patients who have recurrent glioblastoma multiforme.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: glufosfamide
Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Open Label Phase II Study On Glufosfamide Administered As A 60 Minute Infusion Every 3 Weeks In Recurrent Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2001
Detailed Description:

OBJECTIVES: I. Determine the activity of glufosfamide, in terms of objective response rate and/or progression-free survival at 6 months, in patients with recurrent glioblastoma multiforme. II. Determine the duration of objective response in patients treated with this regimen. III. Determine the toxic effects and pharmacokinetic profile of this regimen in these patients.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed glioblastoma multiforme Recurrent disease by CT scan or MRI At least 1 bidimensionally measurable target lesion at least 2 cm in the largest diameter

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014300

Locations
Austria
Kaiser Franz Josef Hospital
Vienna (Wien), Austria, A-1100
France
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, France, 21079
Centre Leon Berard
Lyon, France, 69373
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
CHU Pitie-Salpetriere
Paris, France, 75651
Centre Eugene Marquis
Rennes, France, 35064
Institut Gustave Roussy
Villejuif, France, F-94805
Greece
University of Ioannina
Ioannina, Greece, GR-45110
Israel
Schneider Children's Medical Center of Israel
Petah-Tikva, Israel, 49202
Italy
Azienda Ospedaliera di Padova
Padova (Padua), Italy, 35128
Istituti Fisioterapici Ospitalieri - Roma
Rome, Italy, 00161
Netherlands
Rotterdam Cancer Institute
Rotterdam, Netherlands, 3075 EA
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, 3508 GA
Portugal
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, Portugal, 1093
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Martin J. van Den Bent, MD Daniel Den Hoed Cancer Center at Erasmus Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00014300     History of Changes
Other Study ID Numbers: CDR0000068528, EORTC-16994G-26002
Study First Received: April 10, 2001
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Ifosfamide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012