NCT01172912Unknown2 期
Tandem High-Dose Chemotherapy (HDCT) With Peripheral-Blood Stem-Cell Rescue for Patients With Metastatic Germ-Cell Tumors Failing First-Line Treatment
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2010年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Efficacy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy.
PURPOSE: This phase II trial is studying the side effects of giving high-dose chemotherapy together with stem cell transplant and to see how well it works in treating patients with metastatic germ cell tumors that have not responded to first-line therapy.
详细描述
OBJECTIVES:
- To evaluate the efficacy of high-dose chemotherapy comprising carboplatin and etoposide (CE) in combination with autologous hematopoietic stem cell transplantation using the CE regimen as initial salvage treatment in patients with relapsed or refractory, metastatic germ cell tumors that did not respond to first-line treatment.
- To evaluate the toxicity associated with this regimen in these patients.
- To evaluate biological correlates of outcome in patients with available tissue pre- and post-treatment.
OUTLINE:
- Conventional-dose chemotherapy: Patients receive ifosfamide on days 1 and 2, followed by cisplatin and etoposide on days 3-5, and dexamethasone on days 1-5. Patients undergo leukapheresis daily for stem cell harvest. Patients also receive conventional filgrastim (G-CSF) subcutaneously (SC) once a day beginning 48 hours after completion of chemotherapy until adequate collection of stem cells are obtained. Treatment repeats every 21 days for 1 or 2 courses.
- High-dose (HD) chemotherapy: Patients receive HD carboplatin and etoposide once a day on days 1-3. Treatments repeat every 30-40 days for 2 courses.
- Autologous hematopoietic stem cell transplantation: Patients undergo reinfusion of autologous stem cells on day 6 (after HD chemotherapy on days 1-5). Patients then receive one dose of pegfilgrastim SC beginning 6 hours after completion of stem cell infusion or conventional filgrastim SC once daily beginning 4 days after completion of stem cell infusion and continuing until blood counts recover.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed germ cell tumor (GCT) based on pathologic review at INT Milan
- •Metastatic disease
- •Relapsed or refractory disease
- •Prior chemotherapy treatment for GCT without a pathologic diagnosis due to unequivocal clinical evidence of GCT and an urgent need to start therapy (elevated alpha-fetoprotein [AFP] or human chorionic gonadotropin [HCG] with pattern of metastases consistent with GCT and high tumor burden) allowed
- •Unequivocal progression of measurable disease, consisting of abnormalities on 2-dimensional imaging or raised tumor markers, following 1 line of cisplatin-based chemotherapy as documented by either of the following:
- •Tumor biopsy of new, growing, or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for adjuvant treatment after resection of viable GCT not allowed)
- •Increasing or abnormally elevated serum tumor markers (HCG or AFP) (increasing lactate dehydrogenase [LDH] alone does not constitute progressive disease)
- •Received ≥ 3 and ≤ 6, cisplatin-based chemotherapy courses as part of first-line (initial) chemotherapy and ≤ 6 cisplatin-based chemotherapy courses
- •Brain metastases allowed
- •May be treated with radiotherapy and/or surgery concurrently with cisplatin, ifosfamide, and etoposide regimen
- •Radiotherapy should not be given concurrently with mobilization phase/leukapheresis and high-dose carboplatin and etoposide
- •PATIENT CHARACTERISTICS:
- •WBC ≥ 2,000/µL
- •ANC ≥ 1,500/µL
- •Platelet count ≥ 100,000/µL
- •Creatinine clearance ≥ 50 cc/min (unless renal dysfunction is due to tumor obstructing the ureters, in which case eligibility will be determined by the principal investigator)
- •AST/ALT < 2 times upper limit of normal (ULN) (< 5 times ULN if due to hepatic metastases)
- •Total bilirubin < 1.5 times ULN
- •Ejection fraction ≥ 50% by echocardiogram
- •Negative serology for the following infectious diseases:
- •HIV type 1 and 2
- •Hepatitis B surface antigen (active carriers)
- •Hepatitis C
- •Cytomegalovirus (serum Ag p65 ± PCR confirmation at principal investigator discretion)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from prior surgery
- •At least 3 weeks since prior chemotherapy
- •No prior high-dose chemotherapy with peripheral blood stem cell rescue
- •No more than 1 prior chemotherapy regimen for metastatic disease
排除标准
- 未提供
结局指标
主要结局
Efficacy
Toxicity
Biological correlates of outcome
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Combination Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Mantle Cell LymphomaLymphomaNCT00003541Memorial Sloan Kettering Cancer Center24
已完成
2 期
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed NeuroblastomaNeuroblastomaNCT00017368Children's Oncology Group42
Unknown
1 期
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal CancerFallopian Tube CancerPrimary Peritoneal Cavity CancerOvarian CancerNCT00003064Herbert Irving Comprehensive Cancer Center30
已完成
2 期
High-Dose Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Metastatic Breast CancerBreast CancerNCT00003392UNC Lineberger Comprehensive Cancer Center61
已完成
2 期
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute LeukemiaLeukemiaNCT00008190Herbert Irving Comprehensive Cancer Center