Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Open Label Phase II Study On Glufosfamide Administered As A 60 Minute Infusion Every 3 Weeks In Recurrent Glioblastoma Multiforme

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna (Wien), Austria, A-1100
        • Kaiser Franz Josef Hospital
  • France
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Dijon, France, 21079
        • Centre de Lute Contre le Cancer,Georges-Francois Leclerc
      • Lyon, France, 69373
        • Centre Leon Berard
      • Nantes-Saint Herblain, France, 44805
        • CRLCC Nantes - Atlantique
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75651
        • CHU Pitié-Salpêtrière
      • Rennes, France, 35064
        • Centre Eugene Marquis
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Greece
      • Ioannina, Greece, GR-45110
        • University of Ioannina
  • Israel
      • Petah-Tikva, Israel, 49202
        • Schneider Children's Medical Center of Israel
  • Italy
      • Padova (Padua), Italy, 35128
        • Azienda Ospedaliera Di Padova
      • Rome, Italy, 00161
        • Istituti Fisioterapici Ospitalieri - Roma
  • Netherlands
      • Rotterdam, Netherlands, 3075 EA
        • Rotterdam Cancer Institute
      • Utrecht, Netherlands, 3508 GA
        • Academisch Ziekenhuis Utrecht
  • Portugal
      • Lisbon, Portugal, 1093
        • Instituto Portugues de Oncologia de Francisco Gentil
  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Centre hospitalier universitaire vaudois
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

September 1, 2001

Study Registration Dates

First Submitted

April 10, 2001

First Submitted That Met QC Criteria

March 16, 2004

First Posted (Estimate)

March 17, 2004

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-16994G-26002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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