Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 95
- 主要终点
- Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
研究概览
简要总结
This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Determine the response rate in pediatric patients with recurrent or resistant malignant germ cell tumors (GCT) treated with paclitaxel, ifosfamide, and carboplatin.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this regimen in these patients. II. To Collect tissue for the tumor bank that will aid in the identification of the biological characteristics of recurrent GCT.
OUTLINE: This is a multicenter study.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed (at original diagnosis) extracranial germ cell tumor (GCT) containing 1 of the following malignant elements:
- •Yolk sac tumor (endodermal sinus tumor)
- •Choriocarcinoma
- •Embryonal carcinoma
- •Meets 1 of the following disease criteria:
- •Recurrent malignant disease
- •Chemotherapy-resistant disease
- •Relapsed disease
- •Disease refractory to conventional therapy
- •Measurable disease
- •Must have received a prior first-line chemotherapy regimen that included cisplatin
- •Patients with tumor marker (AFP and/or BHCG) elevation alone or bone scan findings alone are not eligible*
- •Patients with immature teratoma (any grade), germinoma, sex-cord stromal tumors, or recurrent GCT previously treated with surgery alone are not eligible
- •Karnofsky performance status (PS) 50-100% (age > 16 years) OR Lansky PS 50-100% (age ≤ 16 years) OR ECOG PS 0-2
- •Life expectancy ≥ 8 weeks
- •Absolute neutrophil count ≥ 750/mm³
- •Platelet count ≥ 75,000/mm³ (transfusion independent)
- •Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal based on age/gender, as defined by the following:
- •≤ 0.4 mg/dL (1 month to < 6 months of age)
- •≤ 0.5 mg/dL (6 months to < 1 year of age)
- •≤ 0.6 mg/dL (1 to < 2 years of age)
- •≤ 0.8 mg/dL (2 to < 6 years of age)
- •≤ 1.0 mg/dL (6 to < 10 years of age)
- •≤ 1.2 mg/dL (10 to < 13 years of age)
- •≤ 1.4 mg/dL (13 to ≥ 16 years of age) (female)
- •≤ 1.5 mg/dL (13 to < 16 years of age) (male)
- •≤ 1.7 mg/dL (≥ 16 years of age) (male)
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
- •ALT < 2.5 times ULN for age
- •Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by gated radionuclide study
- •No dyspnea at rest
- •No exercise intolerance
- •Pulse oximetry > 94% (if there is clinical indication for determination)
- •Patients with seizure disorder are eligible provided they are on non-enzyme inducing anticonvulsants and seizures are well controlled
- •No CNS toxicity > grade 2
- •No active graft-versus-host disease
- •No allergy to Cremophor EL or castor oil
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other concurrent chemotherapy or immunomodulating agents
- •Recovered from prior chemotherapy, immunotherapy, or radiotherapy
- •At least 1 week since prior growth factors (2 weeks for pegfilgrastim)
- •At least 1 week since prior biologic therapy
- •At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea)
- •At least 2 weeks since prior local palliative radiotherapy (i.e., small port)
- •At least 6 months since prior craniospinal radiotherapy or radiotherapy to ≥ 50% of pelvis
- •At least 6 weeks since other prior substantial bone marrow radiotherapy
- •At least 6 months since prior allogeneic stem cell transplantation
- •Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated
排除标准
- 未提供
研究组 & 干预措施
Treatment (chemotherapy, biological therapy)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Carboplatin (Drug)
Treatment (chemotherapy, biological therapy)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Filgrastim (Biological)
Treatment (chemotherapy, biological therapy)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Ifosfamide (Drug)
Treatment (chemotherapy, biological therapy)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (chemotherapy, biological therapy)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
时间窗: At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)
Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.
次要结局
- The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.(Two cycles of chemotherapy; expected to be 42 days of treatment.)