Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis
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|ClinicalTrials.gov Identifier: NCT00287846|
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : August 30, 2016
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 or disease||Intervention/treatment||Phase|
|Desmoid Tumor||Drug: imatinib mesylate||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||June 2010|
400 to 800 mg/day for a maximal 12 months study duration.
Drug: imatinib mesylate
- Non-progression rate [ Time Frame: 3 months ]
- Non-progression rate [ Time Frame: 12 months ]
- Toxic effects [ Time Frame: 12 months ]
- Tolerance [ Time Frame: 12 months ]
- Response rate [ Time Frame: 5 years ]
- Progression-free survival [ Time Frame: the time between the inclusion date and the progression date ]
- Overall survival [ Time Frame: the time between the inclusion date and the death whathever the cause ]
- Quality of life [ Time Frame: 5 years ]
- Correlation of clinical, biological, and genomic markers with response and long-term stable disease [ Time Frame: 5 years ]
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): NCT00287846
|Study Chair:||Jean-Yves Blay, MD, PhD||Hopital Edouard Herriot - Lyon|