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Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00287846 |
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.
Condition | Intervention | Phase |
---|---|---|
Desmoid Tumor |
Drug: imatinib mesylate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 39 |
Study Start Date: | August 2004 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Tumors must meet the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent nonsteroidal anti-inflammatory drug* if used for fibromatosis
France | |
Centre Alexis Vautrin | Recruiting |
Vandoeuvre-les-Nancy, France, 54511 | |
Contact: Maria Rios, MD 33-3-8359-8461 m.rios@nancy.fnclcc.fr | |
Centre Eugene Marquis | Recruiting |
Rennes, France, 35042 | |
Contact: Pierre Kerbrat, MD, PhD 33-299-253-280 kerbrat@rennes.fnclcc.fr | |
Centre Henri Becquerel | Recruiting |
Rouen, France, 76038 | |
Contact: Cecile Guillemet, MD 33-02-32-02-2237 cecile.guillemet@rouen.fnclcc.fr | |
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | Recruiting |
Besancon, France, 25030 | |
Contact: Loic Chaigneau 33-81-668-240 | |
Centre Hospitalier Universitaire Bretonneau de Tours | Recruiting |
Tours, France, 37044 | |
Contact: Lotfi Benboubker 33-02-4747-3712 | |
Centre Leon Berard | Recruiting |
Lyon, France, 69373 | |
Contact: Isabelle Ray-Coquard, MD 33-4-78-78-26-45 | |
Centre Oscar Lambret | Recruiting |
Lille, France, 59020 | |
Contact: Nicolas Penel, MD 33-3-20-295-920 | |
Centre Paul Papin | Recruiting |
Angers, France, 49036 | |
Contact: Philippe Maillart 33-2-4135-2700 | |
Centre Paul Strauss | Recruiting |
Strasbourg, France, 67065 | |
Contact: Patrick R. Dufour, MD 33-388-252-401 pdufour@strasbourg.fnclcc.fr | |
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Recruiting |
Montpellier, France, 34298 | |
Contact: Didier Cupissol, MD, PhD 33-4-6761-3100 dcupissol@valdorel.fnclcc.fr | |
Centre Regional Francois Baclesse | Recruiting |
Caen, France, 14076 | |
Contact: Corinne Delcambre 33-2-3145-5000 | |
Institut Jean Godinot | Recruiting |
Reims, France, 51056 | |
Contact: Jean-Christophe Eymard, MD 33-03-2650-4444 jc.eymard@reims.fnclcc.fr | |
CHU de la Timone | Recruiting |
Marseille, France, 13385 | |
Contact: Florence Duffaud, MD 33-4-9138-5708 fduffaud@mail.ap-hm.fr | |
CRLCC Nantes - Atlantique | Recruiting |
Nantes-Saint Herblain, France, 44805 | |
Contact: Frederic Rolland, MD 33-2-40-67-99-76 F-rolland@nantes.fnclcc.fr | |
Hopital Edouard Herriot - Lyon | Recruiting |
Lyon, France, 69437 | |
Contact: Jean-Yves Blay, MD, PhD 33-47-211-7398 jy.blay@chu-lyon.fr | |
Hopital Foch | Recruiting |
Suresnes, France, 92151 | |
Contact: Laurent Mignot, MD 33-146-252-168 ext. 2288 | |
Hopital Tenon | Recruiting |
Paris, France, 75970 | |
Contact: Jean-Pierre Lotz, MD 33-1-5601-6058 jean-pierre.lotz@tnn.ap-hop-paris.fr | |
Hopitaux Universitaire de Strasbourg | Recruiting |
Strasbourg, France, 67091 | |
Contact: Jean-Pierre Bergerat, MD 33-03-8811-6220 | |
Institut Bergonie | Recruiting |
Bordeaux, France, 33076 | |
Contact: Nguyen Binh Bui, MD 33-556-333-333 | |
Institut Claudius Regaud | Recruiting |
Toulouse, France, 31052 | |
Contact: Christine Chevreau-Dalbianco, MD 33-56-142-4114 chevreau@icr.fnclcc.fr | |
Institut Curie Hopital | Recruiting |
Paris, France, 75248 | |
Contact: Sophie Piperno-Neumann, MD 33-44-32-4000 | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, F-94805 | |
Contact: Axel Le Cesne, MD 33-1-42-114-316 lecesne@igr.fr | |
Centre Rene Huguenin | Recruiting |
Saint Cloud, France, 92211 | |
Contact: Michelle Tubiana-Hulin, MD 33-1-47-111-515 |
Study Chair: | Jean-Yves Blay, MD, PhD | Hopital Edouard Herriot - Lyon |
Study ID Numbers: | CDR0000441039, FRE-FNCLCC-SARCOME-05/0401, EU-20515 |
Study First Received: | February 6, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00287846 |
Health Authority: | Unspecified |
desmoid tumor |
Imatinib Neoplasms, Connective and Soft Tissue Fibroma Fibromatosis, Aggressive Desmoid tumor |
Fibromatosis Aggressive fibromatosis Aggression Recurrence |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Neoplasms, Connective Tissue Neoplasms, Fibrous Tissue Protein Kinase Inhibitors Pharmacologic Actions |