Evaluation of Patients With Bulky GIST Using Sunitinib

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: Pfizer
• Treatments: Sunitinib

Criteria

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.