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Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00014300
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

European Organisation for Research and Treatment of Cancer - EORTC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Martin J. van Den Bent, MD
Principal Investigator Affiliation Daniel Den Hoed Cancer Center at Erasmus Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries Austria, France, Greece, Israel, Italy, Netherlands, Portugal, Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Kaiser Franz Josef Hospital, Vienna (Wien), Austria

Status

Address

Kaiser Franz Josef Hospital

Vienna (Wien), , A-1100

Centre Jean Perrin, Clermont-Ferrand, France

Status

Address

Centre Jean Perrin

Clermont-Ferrand, , 63011

Dijon, France

Status

Address

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, , 21079

Centre Leon Berard, Lyon, France

Status

Address

Centre Leon Berard

Lyon, , 69373

CRLCC Nantes - Atlantique, Nantes-Saint Herblain, France

Status

Address

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, , 44805

Centre Antoine Lacassagne, Nice, France

Status

Address

Centre Antoine Lacassagne

Nice, , 06189

CHU Pitie-Salpetriere, Paris, France

Status

Address

CHU Pitie-Salpetriere

Paris, , 75651

Centre Eugene Marquis, Rennes, France

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Address

Centre Eugene Marquis

Rennes, , 35064

Institut Gustave Roussy, Villejuif, France

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Address

Institut Gustave Roussy

Villejuif, , F-94805

University of Ioannina, Ioannina, Greece

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Address

University of Ioannina

Ioannina, , GR-45110

Petah-Tikva, Israel

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Address

Schneider Children's Medical Center of Israel

Petah-Tikva, , 49202

Azienda Ospedaliera di Padova, Padova (Padua), Italy

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Address

Azienda Ospedaliera di Padova

Padova (Padua), , 35128

Rome, Italy

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Address

Istituti Fisioterapici Ospitalieri - Roma

Rome, , 00161

Rotterdam Cancer Institute, Rotterdam, Netherlands

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Address

Rotterdam Cancer Institute

Rotterdam, , 3075 EA

Academisch Ziekenhuis Utrecht, Utrecht, Netherlands

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Address

Academisch Ziekenhuis Utrecht

Utrecht, , 3508 GA

Lisbon, Portugal

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Address

Instituto Portugues de Oncologia de Francisco Gentil

Lisbon, , 1093

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

Status

Address

Centre Hospitalier Universitaire Vaudois

Lausanne, , CH-1011

Kantonsspital - St. Gallen, St. Gallen, Switzerland

Status

Address

Kantonsspital - St. Gallen

St. Gallen, , CH-9007