CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 120
- 主要终点
- Number of Participants Allocated to Each ISA
研究概览
简要总结
The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the inclusion criteria below. Additional criteria are specified in the protocol amendment (individual addenda) to which the participant will enroll.
- •Have either measurable or evaluable disease using standard techniques by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
- •The participant has a Lansky (<16 years of age) or Karnofsky (≥16 years of age) performance score of at least
- •Participants must have discontinued all previous treatments for cancer or investigational agents greater than or equal to (≥)7 days after the last dose and must have recovered from clinically significant side effects.
- •The participant has adequate hematologic and organ function.
- •Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to first dose.
- •Both female and male participants of childbearing potential must agree to use highly effective contraceptive precautions during the trial and for at least 3 months following the last dose of study drug.
- •Participants will be ineligible if they meet any of the
排除标准
- •below. Additional criteria are specified in the protocol amendment to which the participant will enroll.
- •Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that, in the opinion of the investigator, could cause unacceptable safety risks or compromise compliance with the protocol.
- •Participants who have active infections requiring therapy.
- •Participants who have had allogeneic bone marrow or solid organ transplant.
- •Participants who have had, or are planning to have, certain invasive procedures.
- •Female participants who are pregnant or breastfeeding.
研究组 & 干预措施
Gemcitabine + Docetaxel (SS ISA)
Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA.
干预措施: Gemcitabine (Drug)
Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.
干预措施: Ramucirumab (Drug)
Irinotecan + Temozolomide (ES ISA)
Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.
干预措施: Temozolomide (Drug)
Abemaciclib + Irinotecan + Temozolomide (ES ISA)
Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.
干预措施: Abemaciclib (Drug)
Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA).
干预措施: Cyclophosphamide (Drug)
Cyclophosphamide + Vinorelbine (DSRCT ISA)
Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.
干预措施: Vinorelbine (Drug)
Cyclophosphamide + Vinorelbine (DSRCT ISA)
Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.
干预措施: Cyclophosphamide (Drug)
Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.
干预措施: Gemcitabine (Drug)
Abemaciclib + Irinotecan + Temozolomide (ES ISA)
Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.
干预措施: Irinotecan (Drug)
Gemcitabine + Docetaxel (SS ISA)
Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA.
干预措施: Docetaxel (Drug)
Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA).
干预措施: Vinorelbine (Drug)
Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.
干预措施: Docetaxel (Drug)
Irinotecan + Temozolomide (ES ISA)
Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.
干预措施: Irinotecan (Drug)
Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA).
干预措施: Ramucirumab (Drug)
Abemaciclib + Irinotecan + Temozolomide (ES ISA)
Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Number of Participants Allocated to Each ISA
时间窗: Baseline up to Week 4
Number of Participants Allocated to Each ISA
次要结局
未报告次要终点