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Brain and Central Nervous System TumorsPhase 2NCT00014300

Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme

A Phase 2 study testing glufosfamide in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 18 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
glufosfamide
How many people
32 participants
Where
18 sitesin 8 countries
Study dates
Jan 2001to Sep 2001
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

18 sites in 8 countries.

18 sites in 8 countries

France8 sites

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre de Lute Contre le Cancer,Georges-Francois Leclerc

    Dijon, 21079

  • Centre Leon Berard

    Lyon, 69373

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Centre Eugene Marquis

    Rennes, 35064

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Italy2 sites

  • Azienda Ospedaliera di Padova

    Padova (Padua), 35128

  • Istituti Fisioterapici Ospitalieri - Roma

    Rome, 00161

Other trials in Italy

Netherlands2 sites

  • Rotterdam Cancer Institute

    Rotterdam, 3075 EA

  • Academisch Ziekenhuis Utrecht

    Utrecht, 3508 GA

Other trials in Netherlands

Switzerland2 sites

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

Other trials in Switzerland

Austria1 site

  • Kaiser Franz Josef Hospital

    Vienna (Wien), A-1100

Other trials in Austria

Greece1 site

  • University of Ioannina

    Ioannina, GR-45110

Other trials in Greece

Israel1 site

  • Schneider Children's Medical Center of Israel

    Petah Tikva, 49202

Other trials in Israel

Portugal1 site

  • Instituto Portugues de Oncologia de Francisco Gentil

    Lisbon, 1093

Other trials in Portugal

About this study

Official title: 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.

Read the 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.

Being tested
glufosfamide
Keywords
recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • glufosfamideDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2004 (estimated)
  2. Study startJan 2001
  3. Primary completionSep 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00014300
Sponsor's protocol ID
EORTC-16994G-26002
Other IDs
EORTC-16994G-26002
Status last verified
Sep 2012
First submitted
10 Apr 2001
Last updated
24 Sep 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing glufosfamide in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 18 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France, Italy, Netherlands, Switzerland, Austria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00014300.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.

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