ABOUT THIS STUDY
- 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.
- 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.
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