A Phase II Study Of Imatinib Mesylate (Gleevec, Formerly Known As STI571; IND 61,135, NSC #716051) In Patients With Refractory Seminoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Response rate defined as either a complete or partial response using RECIST criteria
研究概览
简要总结
Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, refractory, or recurrent stage II or stage III testicular cancer or stage II or stage III ovarian cancer following cisplatin-based chemotherapy
详细描述
OBJECTIVES:
I. Determine the activity of imatinib mesylate in patients with progressive, refractory, or recurrent pure testicular seminoma or ovarian germ cell dysgerminoma after cisplatin-based chemotherapy.
II. Determine the toxicity of this drug in this patient population. III. Determine KIT expression and identify mutations in the c-kit gene in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve a partial response or stable disease with normalization of human chorionic gonadotropin may undergo surgical resection of residual lesions at each tumor status assessment. If residual viable germ cell tumor is present in the resected specimen, patients may resume imatinib mesylate. If no viable germ cell tumor is present in the resected specimen, then no further therapy is administered.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed pure testicular seminoma or ovarian germ cell dysgerminoma
- •Histologic documentation of metastatic/recurrent disease not required
- •Alpha-fetoprotein level must be normal, unless abnormal level is explained by other conditions and approved by the study chair
- •Clinical stage II or III
- •Progressive, refractory, or recurrent disease, meeting at least 1 of the following criteria:
- •Measurable progressive disease
- •Biopsy-proven residual disease
- •Persistently elevated or rising B-human chorionic gonadotropin (HCG) titers, defined as at least 2 values above the upper limit of normal (ULN)
- •Cisplatin-refractory disease without option of potentially curative therapy, meeting 1 of the following criteria:
- •Failed high-dose chemotherapy with peripheral blood stem cell transplantation (PBSCT) or autologous bone marrow transplantation (AuBMT)
- •Ineligible for or refused PBSCT or AuBMT
- •Unlikely to achieve long-term benefit from PBSCT or AuBMT
- •Current evidence of metastatic disease
- •Unidimensionally measurable target lesions
- •At least 20 mm by conventional techniques (e.g., physical examination for clinically palpable lymph nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions surrounded by aerated lung)
- •At least 10 mm by spiral CT scan or MRI
- •If measurable disease is confined to a solitary lesion, then its neoplastic nature must be confirmed by histology
- •Ultrasound may not be used to measure tumor lesions that are not easily accessible clinically
- •Non-measurable/non-target lesions, with HCG at least ULN, including the following:
- •Bone lesions
- •Pleural or pericardial effusions
- •CNS lesions
- •Leptomeningeal disease
- •Irradiated lesions, unless progression documented after radiotherapy
- •Performance status - ECOG 0-2
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9 g/dL (transfusion allowed)
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT/SGPT no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •No other severe and/or uncontrolled concurrent medical illness
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 3 months after study participation
- •See Disease Characteristics
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy
- •No concurrent chemotherapy
- •No concurrent hormonal therapy except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy
- •Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) allowed
- •No concurrent palliative radiotherapy
- •No concurrent grapefruit juice
- •No concurrent warfarin for therapeutic anticoagulation (concurrent mini-dose warfarin [1 mg orally per day] as prophylaxis allowed)
排除标准
- 未提供
研究组 & 干预措施
Treatment (imatinib mesylate and surgical resection)
Patients receive oral imatinib mesylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve a partial response or stable disease with normalization of human chorionic gonadotropin may undergo surgical resection of residual lesions at each tumor status assessment. If residual viable germ cell tumor is present in the resected specimen, patients may resume imatinib mesylate. If no viable germ cell tumor is present in the resected specimen, then no further therapy is administered.
干预措施: imatinib mesylate (Drug)
Treatment (imatinib mesylate and surgical resection)
Patients receive oral imatinib mesylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve a partial response or stable disease with normalization of human chorionic gonadotropin may undergo surgical resection of residual lesions at each tumor status assessment. If residual viable germ cell tumor is present in the resected specimen, patients may resume imatinib mesylate. If no viable germ cell tumor is present in the resected specimen, then no further therapy is administered.
干预措施: therapeutic conventional surgery (Procedure)
Treatment (imatinib mesylate and surgical resection)
Patients receive oral imatinib mesylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve a partial response or stable disease with normalization of human chorionic gonadotropin may undergo surgical resection of residual lesions at each tumor status assessment. If residual viable germ cell tumor is present in the resected specimen, patients may resume imatinib mesylate. If no viable germ cell tumor is present in the resected specimen, then no further therapy is administered.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Response rate defined as either a complete or partial response using RECIST criteria
时间窗: Up to 2 years
Response rate (CR+PR) and exact 95% confidence interval based on the binomial distribution for the response rate will be computed.
次要结局
- Grade 1 or higher toxicities assessed using CTC)version 2(Up to 2 years)
- Duration of response(From first response (CR or PR) to the date of disease progression or death, assessed up to 2 years)
- Disease-free survival(From the date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 2 years)
- Overall survival(From date of initiation of treatment to date of death due to any cause, assessed up to 2 years)
- Proportion of patients with mutations in the c-KIT gene(Up to 2 years)