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A Phase II Study of Five-Year Imatinib (Gleevec®) in Patients at Significant Risk for Recurrence of Primary Gastrointestinal Stromal Tumor
[Protocol 09-061]
- Full Title :
- A PHASE II, NON-RANDOMIZED OPEN-LABEL MULTICENTER STUDY OF 5 YEAR ADJUVANT IMATINIB MESYLATE (GLEEVEC) IN PATIENTS AT SIGNIFICANT RISK FOR RECURRENCE FOLLOWING COMPLETE RESECTION OF PRIMARY GASTROINTESTINAL STROMAL TUMOR (GIST)
- Purpose :
Imatinib (Gleevec) is a drug approved for the treatment of a form of sarcoma called gastrointestinal stromal tumor (GIST) when used for at least one year after surgery to reduce the risk of recurrence. However, the optimal length of imatinib treatment after removal of the initial tumor has not been established.
The goal of this study is to determine the effectiveness of five years of treatment with imatinib in patients at significant risk for recurrence for GIST. Researchers will also examine how different genes affect the response to imatinib and assess patients' overall quality of life.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of GIST that expresses the KIT (CD117) protein and is considered to be at high risk of recurring.
- Imatinib treatment must begin within 12 weeks of surgery to remove the tumor. The tumor must have been a primary GIST without evidence of any spread to any other sites. The patient must be considered at significant risk of tumor recurrence based on its pathologic features.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Ronald DeMatteo at 212-639-5726.
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