poor accrual

The primary purpose of this study is to determine if oral (mouth) delivery prior to tumor removal in patients with gastrointestinal stromal tumor (GIST) results in tumor shrinkage allowing for successful surgery. Therapy will be administered orally and the response of the tumor will be assessed using CTs or MRIs.

Gastrointestinal stromal tumor (GIST) is a rare cancer affecting primarily the digestive tract and sometimes abdominal cavity in adults. The most common site is the stomach followed by the duodenum and small intestine.

Surgery is the mainstay of therapy for GIST patients whose primary tumor is felt to be resectable. Prior to the introduction of Gleevec, patients with inoperable GIST had essentially no therapeutic options. However, sunitinib trials offer options to patients who are Gleevec resistant or have intolerant GIST. Clinical benefit has been demonstrated with positive results in several sunitinib studies of varying phases.

Inclusion Criteria:

• Patients more than 19 years old with pathologically proven GIST which is bulky or marginally resectable
• Patients must have at least one bidimensionally measurable disease site of 5 cm or greater not previously irradiated. Bone lesions do not qualify.
• Patients must have an ECOG performance of greater than or equal to 2, with projected survival of at least three months.
• Patients must have adequate laboratory parameters:

Hematologic: Hb >9.0; WBC >3200 and platelets >100,000/mm3; Hepatic: Bilirubin <2.0 and AST within 4 times upper limit of normal; Renal: Creatinine of less than or equal to 1.6 or eGFR greater than or equal to 50 mL/min

• Men and women who are of childbearing potential must practice strict birth control for the duration of the study.
• Women of childbearing potential must be non-lactating and non-pregnant with a negative pregnancy test within two weeks of trial registration.
• The patient, a witness, and attending physician will have signed an IRB-approved informed consent prior to Sunitinib administration.

Exclusion Criteria:

• Known brain metastases or significant pleural effusion or ascites.
• Uncontrolled hypertension, diabetes, or other medical condition.
• Major surgery within 21 days of registration.
• Patients wtih organ grafts with the exception of prior high dose chemotherapy with autologous bone marrow (or stem cell) transplantation.
• History of seizures, central nervous system disorders, dementia, or psychosis that might preclude adequate informed consent or protocol compliance.
• Prior therapy for GIST.
• A history of HIV or hepatitis virus infection.
• Any recent medical condition which, in the opinion of the investigator, makes the patient unsuitable for study participation.
• Patients with impaired kidney function.

Gastrointestinal stromal tumor comprise 1% of gastrointestinal tumors. There are 6000 new cases per year in the United States without apparent geographic, ethnic, or gender prevalence.

February 2010 to March 2012

This Pilot trial was terminated early due sluggish accrual; thereby, resulting in much smaller numbers.