A Phase II Study of Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma and Melanomas That Arise on Chronically Sun Damaged Skin.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- Best Overall Response
研究概览
简要总结
The purpose of this study is to evaluate how effective imatinib (Gleevec) is in treating acral/lentiginous and mucosal melanoma which has spread to other parts of the body in patients who's disease carries a c-kit mutation. Imatinib is a protein-kinase inhibitor. It is believed that imatinib may be effective in blocking signals on certain cancer cells which allow the malignant cells to multiply and spread.
详细描述
OBJECTIVES:
Primary
- To determine the response rate of patients with metastatic mucosal, acral/lentiginous, or chronically sun damaged melanomas to treatment with of imatinib.
- To determine the time to progression.
Secondary
- To correlate c-kit mutational status with response to therapy.
- To evaluate the use of FDG-PET scanning in determining early biologic response to therapy.
- Tolerability of imatinib.
- To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets.
- To correlate c-kit amplification status with response to therapy.
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
- •Melanomas that arise on chronically sun damaged skin and have pathologic evidence of solar elastosis
- •History of primary mucosal or acral/lentiginous melanoma
- •Histologically documented stage IV metastatic melanoma
- •ECOG performance status 0,1, or 2
- •Estimated life expectancy of 6 months or greater
- •Age 18 years or older
- •Creatinine < 1.5 x ULN
- •ANC > 1500 ul
- •Platelets > 100,000 ul
- •Total bilirubin, AST, and ALT < 2 x ULN
- •Amylase and lipase < 1.5 x ULN
- •C-kit mutation documented from either primary or metastatic tumor site
- •> 4 weeks from prior chemotherapy or investigational drug
- •At least one measurable site of disease as defined by at least 1 cm in greatest dimension
排除标准
- •Severe and/or uncontrolled medical disease
- •Pregnant or nursing mothers
- •Any other significant medical, surgical, or psychiatric condition that my interfere with compliance
- •Patient is < 5 years free of another primary malignancy except: basal cell skin cancer or a cervical carcinoma in situ
- •Concurrent treatment with Warfarin
- •Prior treatment with c-kit inhibitor
- •Patient with Grade III/IV cardiac problems as defined by NYHA criteria
- •No H2 blockers or proton pump inhibitors
- •Known brain metastasis
- •Known chronic liver disease
- •Known diagnosis of HIV infection
- •Previous radiotherapy to > 25% of the bone marrow
- •Major surgery within 2 weeks prior to study entry
- •Patient has received any other investigational agent within 28 days of first study drug dosing
- •Chemotherapy within 4 weeks prior to study entry
研究组 & 干预措施
Treatment Arm
Imatinib
干预措施: Imatinib (Drug)
结局指标
主要结局
Best Overall Response
时间窗: Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).
Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.
次要结局
- Time to Progression(Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment and every 3 months long-term. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).)
- Overall Survival(Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 10.6 months (range 3.7-27.1).)
研究者
F. Stephen Hodi, MD
Melanoma Disease Center Director
Dana-Farber Cancer Institute