Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sunitinib pill
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.
干预措施: Sunitinib (Drug)
Sunitinib pill
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.
干预措施: Surgery (Procedure)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 6 months
次要结局
- Alteration in Diffusion and Vascularity Kinetics(MRI at baseline, Week 2 and Week 6)
- Measurable Disease Response Rate(FDG PET scan at baseline and Week 2, CT scan at baseline and Week 12)
研究者
James Posey, MD
Associate Professor
University of Alabama at Birmingham