EUCTR2005-005219-36-GB进行中（未招募）1 期
A Phase 2 Single-Arm Study of Gemcitabine in Combination with Oxaliplatin in Pediatric Patients with Relapsed or Refractory Neuroblastoma or Miscellaneous Solid Non-CNS Tumors - N/A
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients are eligible to be included in the study only if they meet all of the following criteria:
- •[1] Histologically proven malignancy (at diagnosis): either neuroblastoma or other non-CNS solid tumors (excluding osteosarcoma).
- •[2] Measurable primary and/or metastatic disease:
- •For neuroblastoma measurable disease will be defined by the modified International Neuroblastoma Staging System and International Neuroblastoma Response Criteria (Brodeur et al. 1993).
- •For miscellaneous solid non-CNS tumors measurable disease will be defined by RECIST (Therasse et al. 2000).
- •[3] Relapsed or refractory tumors in which standard approaches to treatment have failed.
- •[4] No more than one salvage therapy for relapsed or refractory disease.
- •[5] 6 months to <18 years of age.
- •[6] Lansky play score ?70%, or Eastern Cooperative Oncology Group (ECOG) performance status ?1 (where more appropriate).
- •[7] Life expectancy ?3 months.
- •[8] Adequate organ function including the following:
- •Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ?1.0 ? 109/L, platelets ?100 ? 109/L (in case of bone marrow disease: ?75 ? 109/L), and hemoglobin ?8.0g/dL.
- •Hepatic: bilirubin ?1.5 times the upper limit of normal (? ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ?2.5 ? ULN (AST, and ALT ?5 ? ULN is acceptable if liver has tumor involvement).
- •Renal: serum creatinine ?1.5 ? ULN for age, according to local lab value. If serum creatinine >1.5 ? ULN for age, then creatinine clearance (or radioisotope GFR) must be >70 ml/min/1.73 m2.
- •[9] Must have had their last dose of chemotherapy at least 3 weeks prior to study enrollment (first dose of study treatment); 2 weeks if the prior chemotherapy was single-agent vincristine; 6 weeks if the prior chemotherapy contained nitrosoureas.
- •Must have had their last dose of radiotherapy at least 4 weeks prior to study enrollment (first dose of study treatment);
- •Patients must have recovered from the acute toxic effects of all prior therapy before enrollment into the study.
- •[10] Able to comply with scheduled follow up and with management of toxicity.
- •[11] All patients with reproductive potential must practice an effective method of birth control while on study. Female patients with childbearing potential must have a negative pregnancy test within 7 days before study treatment.
- •[12] Written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •[13] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •[14] Concurrent administration of any other antitumor therapy.
- •[15] Have previously completed or withdrawn from this study or any other study investigating gemcitabine or oxaliplatin.
- •[16] Have a serious concomitant systemic disorder (for example, active infection including HIV, or cardiac disease) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study.
- •[17] Have symptomatic brain metastases.
- •[18] re-existing sensory or motor neuropathy >Grade 2 (excluding neuropathy due to disease).
- •[19] History of allergic reaction to platinum compounds.
- •[20] Are pregnant or breastfeeding.
研究者
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