A Phase II Trial of Neoadjuvant/Adjuvant STI-571 (Gleevec NSC #716051) for Primary and Recurrent Operable Malignant GIST Expressing the KIT Receptor Tyrosine Kinase (CD117)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Rate of Disease Progression at 2 Years
研究概览
简要总结
Phase II trial to study the effectiveness of neoadjuvant and adjuvant imatinib mesylate in treating patients who are undergoing surgery for primary or recurrent malignant gastrointestinal stromal tumor. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving imatinib mesylate before and after surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining after surgery.
详细描述
OBJECTIVES:
I. Determine the progression-free survival of patients with primary or recurrent potentially resectable malignant gastrointestinal stromal tumor treated with neoadjuvant and adjuvant imatinib mesylate.
II. Determine the objective response rate of patients treated with this drug. III. Determine the safety of this drug in these patients.
OUTLINE:
Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed malignant gastrointestinal stromal tumor
- •Potentially resectable primary disease
- •Potentially resectable recurrent disease
- •Local or intra-abdominal/pelvic metastatic disease
- •Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block
- •Primary disease must be visceral, intra-abdominal, or pelvic in origin
- •At least 1 unidimensionally measurable lesion
- •At least 5 cm for primary disease
- •At least 2 cm for recurrent disease
- •At least 1 viable core biopsy tumor specimen obtained within 8 weeks before registration
- •Performance status - Zubrod 0-2
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT/AST no greater than 2.5 times ULN
- •No uncontrolled chronic liver disease
- •Creatinine no greater than 1.5 times ULN
- •No uncontrolled chronic renal disease
- •No New York Heart Association class III or IV cardiac disease
- •Must be able to lie still in the PET scanner for approximately 1-2 hours
- •No uncontrollable hyperglycemia
- •No medical or psychological condition that would preclude study participation
- •No severe or uncontrolled medical disease
- •No active uncontrolled infection
- •No known or suspected hypersensitivity to any component of the study drug
- •Any prior malignancy is allowed provided patient remains disease free from that malignancy
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 3 months after study participation
- •At least 28 days since prior biologic therapy
- •No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- •At least 28 days since prior chemotherapy
- •At least 28 days since prior radiotherapy
- •See Disease Characteristics
- •At least 28 days since prior investigational drugs
- •At least 28 days since prior imatinib mesylate
- •No concurrent therapeutic doses of warfarin
- •Concurrent low-molecular weight heparin or mini-dose warfarin (1 mg per day) prophylaxis is allowed
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
干预措施: Conventional Surgery (Procedure)
Arm I
Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
干预措施: Imatinib Mesylate (Drug)
结局指标
主要结局
Rate of Disease Progression at 2 Years
时间窗: From registration to two years
Kaplan-Meier estimate of disease progression rate. Disease progression is determined by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist_guideline.pdf
次要结局
- Percentage of Patients With Major Toxicity (Toxicity Grade ≥ 3)(Analysis occurs after all patients have been on study for at least 2 years. Measured from start of treatment to end of follow-up, to a maximum of 4.95 years.)
- FDG-PET as Biological Marker of Metabolic Response(MR) During Imatinib Mesylate (IM) Treatment, in Patients With GIST Who Are naı¨ve to Tyrosine Kinase Inhibitor Therapy(change from baseline to 1 week post therapy)
- Rates of Objective Response (Complete, Partial, and Stable)(Pretreatment and prior to surgery (at 4-10 weeks, based on surgery timing))