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Evaluation of Patients With Bulky GIST Using Sunitinib

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tumor

Intervention: Sunitinib (Drug); Surgery (Procedure)

Phase: N/A

Status: Active, not recruiting

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
James A. Posey, M.D., Principal Investigator, Affiliation: University of Alabama at Birmingham

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.

Clinical Details

Official title: Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST

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

Primary outcome: To characterize the safety/tolerability of sunitinib given neoadjuvantly.

Secondary outcome:

To determine the degree of alteration in diffusion and vascular kinetics in GIST tumors receiving sunitinib therapy.

To describe any evidence of anti-tumor efficacy and correlate it with any alteration of vascular kinetics/diffusion and cKIT or PDGFr mutation.

Detailed 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.

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Additional Information

Starting date: October 2009
Last updated: September 24, 2013

Page last updated: August 23, 2015

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