Multicenter Single Arm Phase II Study of Single Agent Palifosfamide in Recurrent and Incurable Germ Cell Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Overall Response Rate (Defined as Partial Response or Complete Response)
研究概览
简要总结
This phase II trial studies how well palifosfamide works in treating patients with recurrent germ cell tumors. Drugs used in chemotherapy, such as palifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing
详细描述
PRIMARY OBJECTIVES:
I. To determine the response rate (complete response [CR]+partial response [PR]) of single agent palifosfamide in patients with refractory germ cell tumors.
SECONDARY OBJECTIVES:
I. To determine the duration of remission. II. To determine progression free and overall survival. III. To assess toxicity and tolerability of palifosfamide in patients with germ cell tumors.
OUTLINE:
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
- •Patients must have histological or serological proof of metastatic germ cell neoplasm (gonadal or extragonadal primary) with disease not amenable to cure with either surgery or chemotherapy; patients with seminoma and nonseminoma are eligible, as are women with ovarian germ cell tumors
- •Patients must have evidence of recurrent or metastatic carcinoma by one or more of the criteria specified in the protocol
- •Patients must have received initial cisplatin based combination therapy (such as bleomycin, etoposide and cisplatin [BEP], etoposide and cisplatin [EP], VP-16 plus ifosfamide plus cisplatin [VIP] or similar regimens) AND demonstrated progression following the administration of at least one 'salvage' regimen for advanced germ cell neoplasm (such as high dose chemotherapy, paclitaxel/ifosfamide/cisplatin [TIP] or vinblastine, ifosfamide and cisplatin [VeIP])
- •Patients must have documented "failure" of prior therapy as defined in the protocol
- •Patients are eligible after first line platinum based chemotherapy if their disease has relapsed and they have primary mediastinal non seminomatous germ cell tumor (PMNSGCT) or late relapse (> 2 years) not amenable to surgical resection
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Laboratory test results must be within ranges established in the protocol
- •Potential subject must have the ability to understand (as judged by the treating physician) and willingness to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information;
- •Females of childbearing potential must not be pregnant or breast-feeding; male and female patients of reproductive potential must agree to use a highly reliable method of birth control from the screening visit through 28 days after the last dose of study drug
排除标准
- •No active clinically serious infections as judged by the treating investigator (> CTCAE grade 2) including known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or active hepatitis C
- •No presence of, or history of any illness or injury to the urinary tract which may make the patient more susceptible to acute renal insufficiency in the case of potential renal adverse events
- •Patients must not have any cardiac disorders as defined in the protocol
- •No history of psychiatric illness/social situations that would limit compliance with study requirements
- •Patients must be at least 4 weeks post major surgery or significant traumatic injury at time of study registration
- •Patients must be at least 7 days post any minor surgical procedure, excluding placement of a vascular access device at the time of study registration
- •Patients must not have a known sensitivity to any component of palifosfamide or its known excipients
- •Patients with active central nervous system (CNS) metastases are excluded
- •Patients must not have previously been exposed to palifosfamide
- •Patients must have at least 3 weeks after previous radiotherapy or chemotherapy and have recovered from all major toxicities (except alopecia or grade 1 or 2 neuropathy) at the time of registration
研究组 & 干预措施
Treatment (palifosfamide)
Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: palifosfamide (Drug)
结局指标
主要结局
Overall Response Rate (Defined as Partial Response or Complete Response)
时间窗: Up to 2 years
The percent of patients who were shown as having a partial remission or better based on definitions of response in RECIST 1.1. At least a 30% decrease in the sum of the diameters of target lesions, in reference to baseline sum diameters, needs to be confirmed to be considered as partial response or better. Note: There were no patients with a partial or complete response.
次要结局
- Duration of Remission in Patients Who Achieve a Partial or Complete Response(Up to 2 years)
- Treatment Related Adverse Events Grade 3 or Higher(Up to 2 years)
- Progression Free Survival (PFS)(Up to 2 years)
- Overall Survival(Up to 2 years)