Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis
Recruitment status was Recruiting
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicentric Phase I/II Study Evaluating the Efficacy and Toxicity of Imatinib in Adult Patients With Aggressive Fibromatosis That Cannot be Treated by Surgery or Curative Radiotherapy|
- Non-progression rate at 3 months [ Designated as safety issue: No ]
- Non-progression rate at 12 months [ Designated as safety issue: No ]
- Toxic effects [ Designated as safety issue: Yes ]
- Tolerance [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Correlation of clinical, biological, and genomic markers with response and long-term stable disease [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
- Determine the non-progression rate in patients with recurrent or refractory aggressive fibromatosis after 3 months of treatment with imatinib mesylate.
- Determine the non-progression rate in patients after being treated with this drug for 12 months.
- Determine the toxic effects of this drug in these patients.
- Determine the tolerance to this drug in these patients.
- Determine the response rate in patients treated with this drug
- Determine progression free and overall survival of patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
- Correlate clinical, biological, and genomic markers with response and long-term stable disease in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed periodically.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287846
|Centre Paul Papin||Recruiting|
|Angers, France, 49036|
|Contact: Philippe Maillart 33-2-4135-2700|
|Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz||Recruiting|
|Besancon, France, 25030|
|Contact: Loic Chaigneau 33-81-668-240|
|Bordeaux, France, 33076|
|Contact: Nguyen Binh Bui, MD 33-556-333-333|
|Centre Regional Francois Baclesse||Recruiting|
|Caen, France, 14076|
|Contact: Corinne Delcambre 33-2-3145-5000|
|Centre Oscar Lambret||Recruiting|
|Lille, France, 59020|
|Contact: Nicolas Penel, MD 33-3-20-295-920|
|Hopital Edouard Herriot - Lyon||Recruiting|
|Lyon, France, 69437|
|Contact: Jean-Yves Blay, MD, PhD 33-47-211-7398 firstname.lastname@example.org|
|Centre Leon Berard||Recruiting|
|Lyon, France, 69373|
|Contact: Isabelle Ray-Coquard, MD 33-4-78-78-26-45|
|CHU de la Timone||Recruiting|
|Marseille, France, 13385|
|Contact: Florence Duffaud, MD 33-4-9138-5708 email@example.com|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle||Recruiting|
|Montpellier, France, 34298|
|Contact: Didier Cupissol, MD, PhD 33-4-6761-3100 firstname.lastname@example.org|
|CRLCC Nantes - Atlantique||Recruiting|
|Nantes-Saint Herblain, France, 44805|
|Contact: Frederic Rolland, MD 33-2-40-67-99-76 Femail@example.com|
|Paris, France, 75970|
|Contact: Jean-Pierre Lotz, MD 33-1-5601-6058 firstname.lastname@example.org|
|Institut Curie Hopital||Recruiting|
|Paris, France, 75248|
|Contact: Sophie Piperno-Neumann, MD 33-44-32-4000|
|Institut Jean Godinot||Recruiting|
|Reims, France, 51056|
|Contact: Jean-Christophe Eymard, MD 33-03-2650-4444 email@example.com|
|Centre Eugene Marquis||Recruiting|
|Rennes, France, 35042|
|Contact: Pierre Kerbrat, MD, PhD 33-299-253-280 firstname.lastname@example.org|
|Centre Henri Becquerel||Recruiting|
|Rouen, France, 76038|
|Contact: Cecile Guillemet, MD 33-02-32-02-2237 email@example.com|
|Centre Rene Huguenin||Recruiting|
|Saint Cloud, France, 92211|
|Contact: Michelle Tubiana-Hulin, MD 33-1-47-111-515|
|Centre Paul Strauss||Recruiting|
|Strasbourg, France, 67065|
|Contact: Patrick R. Dufour, MD 33-388-252-401 firstname.lastname@example.org|
|Hopitaux Universitaire de Strasbourg||Recruiting|
|Strasbourg, France, 67091|
|Contact: Jean-Pierre Bergerat, MD 33-03-8811-6220|
|Suresnes, France, 92151|
|Contact: Laurent Mignot, MD 33-146-252-168 ext. 2288|
|Institut Claudius Regaud||Recruiting|
|Toulouse, France, 31052|
|Contact: Christine Chevreau-Dalbianco, MD 33-56-142-4114 email@example.com|
|Centre Hospitalier Universitaire Bretonneau de Tours||Recruiting|
|Tours, France, 37044|
|Contact: Lotfi Benboubker 33-02-4747-3712|
|Centre Alexis Vautrin||Recruiting|
|Vandoeuvre-les-Nancy, France, 54511|
|Contact: Maria Rios, MD 33-3-8359-8461 firstname.lastname@example.org|
|Institut Gustave Roussy||Recruiting|
|Villejuif, France, F-94805|
|Contact: Axel Le Cesne, MD 33-1-42-114-316 email@example.com|
|Study Chair:||Jean-Yves Blay, MD, PhD||Hopital Edouard Herriot - Lyon|