Overview

This trial is active, not recruiting.

Condition tumor
Treatments sunitinib, surgery
Targets VEGF, FLT-3, KIT, PDGF
Sponsor University of Alabama at Birmingham
Collaborator Pfizer
Start date October 2009
End date September 2014
Trial size 5 participants
Trial identifier NCT01054911, F090910001, UAB 0855

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.
sunitinib SUTENT (Sunitinib)
All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.
surgery
Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16.

Primary Outcomes

Measure
To characterize the safety/tolerability of sunitinib given neoadjuvantly.
time frame: ~24 months

Secondary Outcomes

Measure
To determine the degree of alteration in diffusion and vascular kinetics in GIST tumors receiving sunitinib therapy.
time frame: ~24 months
To describe any evidence of anti-tumor efficacy and correlate it with any alteration of vascular kinetics/diffusion and cKIT or PDGFr mutation.
time frame: ~24 months

Eligibility Criteria

Male or female participants at least 19 years old.

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.

Additional Information

Official title Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST
Principal investigator James A. Posey, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.