High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Number of Participants With 2-year Event-Free Survival (EFS)
研究概览
简要总结
The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug combinations will also be studied.
This is an investigational study. Gemcitabine, docetaxel, melphalan, ifosfamide, carboplatin, and etoposide are all FDA-approved and commercially available for the treatment of germ-cell tumors.
Up to 67 patients will be enrolled in this study.
详细描述
The Study Drugs:
Carboplatin, melphalan, and ifosfamide are designed to damage the DNA (the genetic material) of cancer cells, which may cause the cancer cells to die.
Docetaxel and etoposide are designed to stop the growth of cancer cells, which may cause the cancer cells to die.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may also help docetaxel, carboplatin, and melphalan to be more effective by stopping tumor cells from repairing damage caused by these drugs.
Study Drug Administration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, age 12 to 65 years.
- •Patients with seminomatous or nonseminomatous germ-cell tumors (GCT) in one of the following groups: A) First relapse or progression or second response with an intermediate or high risk according to the Beyer model. B) Second relapse or beyond.
- •Adequate renal glomerular and tubular function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL, and urinary protein excretion </=500 mg/day.
- •Adequate hepatic function, as defined by ALT and AST </=3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase </=2 x ULN or considered not clinically significant.
- •Adequate pulmonary function with FEV1 (Forced expiratory volume in the first second), FVC (Forced vital capacity) and DLCO (diffusing capacity of the lung for carbon monoxide) >/=50% of predicted, corrected for volume and hemoglobin.
- •Adequate cardiac function with LVEF (left ventricular ejection fraction) >/=40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- •Zubrod performance status 0-
- •A minimum apheresis collection of 5 million CD34+ cells/kg of autologous hematopoietic progenitor cells (AHPC).
- •Written informed consent by patients and/ or their parents or legal guardians. Assent for those patients inclusive of ages 12 to 17.
排除标准
- •Growing teratoma syndrome, defined as enlarging tumor masses with normal serum markers during chemotherapy for nonseminomatous GCT.
- •Major surgery within 30 days before the initiation of study treatment
- •Radiotherapy within 21 days prior to initiation of study treatment
- •Prior whole brain irradiation.
- •Patients with active central nervous system (CNS) disease, defined as brain or meningeal metastases that are not in complete remission.
- •Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/=10,000 copies/mL, or >/= 2,000 IU/mL).
- •Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients who either show chronic hepatitis C or positive hepatitis C serology.
- •Active infection requiring parenteral antibiotics.
- •HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts
- •Patients who have had a previous autologous or allogeneic stem cell transplant in the previous 12 months.
- •Positive pregnancy test in a female patient of childbearing potential defined as not post menopausal for twelve months or no previous surgical sterilization.
研究组 & 干预措施
Cycle # 1
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
干预措施: Gemcitabine (Drug)
Cycle # 1
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
干预措施: Docetaxel (Drug)
Cycle # 1
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
干预措施: Melphalan (Drug)
Cycle # 1
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
干预措施: Carboplatin (Drug)
Cycle # 1
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
干预措施: Stem Cell Transplant (Procedure)
Cycle #2
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
干预措施: Carboplatin (Drug)
Cycle #2
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
干预措施: Mesna (Drug)
Cycle #2
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
干预措施: Ifosfamide (Drug)
Cycle #2
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
干预措施: Etoposide (Drug)
Cycle #2
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
干预措施: Stem Cell Transplant (Procedure)
结局指标
主要结局
Number of Participants With 2-year Event-Free Survival (EFS)
时间窗: 2 Years
Event-free survival estimated from the first day of High-Dose Course Cycle #1 (Day -6) until tumor progression, relapse, or death from any cause.
次要结局
- Overall Survival(1 year post treatment)