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Nitrocamptothecin in Treating Patients With 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 nitrocamptothecin in treating patients who have 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 confirmed by CT or MRI Bidimensionally measurable disease At least one lesion with the largest diameter at least 2 cm.PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN in case of liver metastases) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No history of ischemic heart disease in past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior or concurrent malignancies except cone biopsied carcinoma of the cervix or adequately treated basal or squamous cell skin carcinoma No other unstable systemic disease No active uncontrolled infection No psychological, familial, sociological, or geographical condition that would preclude study.PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior adjuvant chemotherapy No other prior or concurrent chemotherapy allowed Endocrine therapy: Concurrent corticosteroids allowed Stable or decreasing dose for at least 2 weeks Radiotherapy: No high dose radiotherapy, stereotactic radiosurgery, or internal radiotherapy unless recurrence is histologically confirmed At least 3 months since prior radiotherapy to the brain Surgery: No prior surgery for recurrent brain tumor except biopsy At least 3 months since prior surgery for primary brain tumor Other: No other concurrent anticancer therapy No other concurrent investigational therapy

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.

NCT00005826
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.

Eric Raymond, MD, PhD
Principal Investigator Affiliation Gustave Roussy, Cancer Campus, Grand Paris
Agency Class

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

Other
Overall Status Completed
Countries Belgium, France, Italy, Netherlands, Spain, Switzerland
Conditions

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

Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • I. Assess the therapeutic activity and toxicities of nitrocamptothecin in patients with glioblastoma multiforme.
  • II. Determine the overall response, duration of response, and progression free survival of these patients after this treatment.
OUTLINE: This is a multicenter study. Patients receive nitrocamptothecin orally daily on days 1-5. Treatment continues every 7 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression in the absence of further treatment. PROJECTED ACCRUAL: A total of 14-25 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

Universitair Ziekenhuis Antwerpen, Edegem, Belgium

Status

Address

Universitair Ziekenhuis Antwerpen

Edegem, , B-2650

Centre Jean Perrin, Clermont-Ferrand, France

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Address

Centre Jean Perrin

Clermont-Ferrand, , 63011

Dijon, France

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Address

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, , 21079

Centre Leon Berard, Lyon, France

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Address

Centre Leon Berard

Lyon, , 69373

CRLCC Nantes - Atlantique, Nantes-Saint Herblain, France

Status

Address

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, , 44805

Centre Eugene Marquis, Rennes, France

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Address

Centre Eugene Marquis

Rennes, , 35062

Centre Henri Becquerel, Rouen, France

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Address

Centre Henri Becquerel

Rouen, , 76038

Institut Gustave Roussy, Villejuif, France

Status

Address

Institut Gustave Roussy

Villejuif, , F-94805

Azienda Ospedaliera di Padova, Padua, Italy

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Address

Azienda Ospedaliera di Padova

Padua, , 35128

Amsterdam, Netherlands

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Address

Academisch Ziekenhuis der Vrije Universiteit

Amsterdam, , 1117 MB

Hospital Universitario 12 de Octubre, Madrid, Spain

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Address

Hospital Universitario 12 de Octubre

Madrid, , 28041

Ospedale San Giovanni, Bellinzona, Switzerland

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Address

Ospedale San Giovanni

Bellinzona, , CH-6500

Clinique De Genolier, Genolier, Switzerland

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Address

Clinique De Genolier

Genolier, , Ch-1272