A Phase I/II Study of Sunitinib in Young Patients with Advanced Gastrointestinal Stromal Tumors

Protocol
12-226
Full Title
A Phase I/II Study of Sunitinib in Young Patients with Advanced Gastrointestinal Stromal Tumor
Phase
I/II
Disease Status
Newly Diagnosed & Relapsed/Refractory
Purpose

Sunitinib is approved for the treatment of gastrointestinal stromal tumors (GIST) in adults whose tumors continued to grow despite receiving the drug imatinib. However, sunitinib has not yet been assessed in children with advanced GIST. The purpose of this study is to evaluate the safety and effectiveness of sunitinib in patients with advanced GIST who are under 21 years of age.

Sunitinib inhibits the development of blood vessels that tumors need to grow and spread. It is a pill that is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • This study is open to patients with advanced inoperable GIST who are at least 6 years of age and under age 21.
  • Patients must have experienced continued growth of GIST despite imatinib therapy or may not have been candidates for imatinib.
  • At least 4 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.

For more information and to inquire about eligibility for this study, please contact Dr. Heather Magnan at 212-639-7937.

Disease(s)
Sarcomas: Soft Tissue Sarcoma
Upper Gastrointestinal
Locations
Related Diseases

Cancer Clinical Trials: Personalizing for Each Patient

Join our experts for a discussion of clinical trials on November 18. Clinical trials can give patients access to new drugs and other treatments before they are widely available, but how do you know if a trial is right for you?

Learn more »