Nitrocamptothecin in Treating Patients With Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT00005826|
Recruitment Status : Completed
First Posted : June 18, 2004
Last Update Posted : September 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: rubitecan||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Official Title:||Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Glioblastoma Multiforme|
|Study Start Date :||March 2000|
|Actual Primary Completion Date :||September 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005826
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre de Lute Contre le Cancer,Georges-Francois Leclerc|
|Dijon, France, 21079|
|Centre Leon Berard|
|Lyon, France, 69373|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Centre Eugene Marquis|
|Rennes, France, 35062|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Azienda Ospedaliera di Padova|
|Padua, Italy, 35128|
|Academisch Ziekenhuis der Vrije Universiteit|
|Amsterdam, Netherlands, 1117 MB|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Ospedale San Giovanni|
|Bellinzona, Switzerland, CH-6500|
|Clinique De Genolier|
|Genolier, Switzerland, Ch-1272|
|Study Chair:||Eric Raymond, MD, PhD||Gustave Roussy, Cancer Campus, Grand Paris|