Evaluation of Patients With Bulky GIST Using Sunitinib

Tumor Clinical Trial

Official title:

Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01054911
• Other study ID #: F090910001
• Secondary ID: UAB 0855
• Status: Active, not recruiting
• Phase: N/A
• First received: January 20, 2010
• Last updated: September 24, 2013
• Start date: October 2009
• Est. completion date: September 2015

Study information

• Verified date: August 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumor

Intervention

Drug:
• Sunitinib
All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.

Procedure:
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the safety/tolerability of sunitinib given neoadjuvantly.		~24 months	Yes
Secondary	To determine the degree of alteration in diffusion and vascular kinetics in GIST tumors receiving sunitinib therapy.		~24 months	No
Secondary	To describe any evidence of anti-tumor efficacy and correlate it with any alteration of vascular kinetics/diffusion and cKIT or PDGFr mutation.		~24 months	No