NCT00014300

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
8 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2001

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2001

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

March 17, 2004

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

April 10, 2001

Last Update Submit

September 20, 2012

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult giant cell glioblastomaadult gliosarcoma

Interventions

glufosfamideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (18)

Kaiser Franz Josef Hospital

Vienna (Wien), A-1100, Austria

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Centre Eugene Marquis

Rennes, 35064, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

University of Ioannina

Ioannina, GR-45110, Greece

Location

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

Location

Azienda Ospedaliera di Padova

Padova (Padua), 35128, Italy

Location

Istituti Fisioterapici Ospitalieri - Roma

Rome, 00161, Italy

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3508 GA, Netherlands

Location

Instituto Portugues de Oncologia de Francisco Gentil

Lisbon, 1093, Portugal

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaGliosarcoma

Interventions

beta-D-glucosylisophosphoramide mustard

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Martin J. van Den Bent, MD

    Daniel Den Hoed Cancer Center at Erasmus Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2001

First Posted

March 17, 2004

Study Start

January 1, 2001

Primary Completion

September 1, 2001

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

AU(1)PT(1)GR(1)IL(1)NL(2)CH(2)IT(2)FR(8)