NCT01802567已完成不适用
A Feasibility Trial Using Molecular-Guided Therapy for the Treatment of Patients With Relapsed and Refractory Childhood Cancer
Giselle Sholler26 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2013年3月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 26
- 主要终点
- Determine Feasibility Using Days From the Date of Biopsy to Date of Start of Treatment
研究概览
简要总结
The purpose of this study is to test the feasibility (ability to be done) of experimental technologies to determine a tumor's molecular makeup (gene expression profile) and mutations. This technology called the "Pediatric Gene Analysis Platform" includes a genomic report (gene expression profile) and a DNA Mutation Panel Report that are being used to discover new ways to understand cancers and potentially predict the best treatments for patients with cancer in the future.
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
- 13 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histologically proven neuroblastoma, brain tumor, or rare tumor and confirmation of refractory or recurrent disease with histologic confirmation at diagnosis or at the time of recurrence/progression
- •Subjects must be age >12 months at enrollment.
- •Subjects must be age ≤ 21 years at initial diagnosis.
- •Subjects must have measurable disease as demonstrated by residual abnormal tissue at a primary or metastatic site measuring more than 1 cm in any dimension by standardized imaging (CT or MRI); tumor must be accessible for biopsy. Patients with bone marrow only disease expected to be >75% tumor are eligible to enroll.
- •Current disease state must be one for which there is currently no known curative therapy
- •Lansky or Karnofsky Score must be more than 50
- •Subjects without bone marrow metastases must have an ANC > 750/μl
- •Adequate liver function must be demonstrated, defined as:
- •Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND
- •SGPT (ALT) < 10 x upper limit of normal (ULN) for age
- •A negative serum pregnancy test is required for female participants of child bearing potential (≥13 years of age or after onset of menses)
- •Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
- •Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines. Voluntary consent for optional biology studies will be included.
排除标准
- •Subjects who have received any cytotoxic chemotherapy within the last 7 days prior to enrollment and 14 days prior to study treatment start date.
- •Subjects who have received any radiotherapy to the primary sample site within the last 14 days (radiation may be included in treatment decision after biopsy).
- •Subjects receiving anti-tumor therapy for their disease or any investigational drug concurrently
- •Subjects with serious infection or a life-threatening illness (unrelated to tumor) that is > Grade 2 (NCI CTCAE V4.0), or active, serious infections requiring parenteral antibiotic therapy.
- •Subjects with any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study
结局指标
主要结局
Determine Feasibility Using Days From the Date of Biopsy to Date of Start of Treatment
时间窗: Date from biopsy to completion of 1 cycle of therapy, generally about 30 days
Days to treatment is one data point that will be used in order to determine feasibility. The definition of feasibility for this study will include: "Enrollment onto study, RNA expression profile completed, DNA Mutation Panel completed, genomic analysis and report generation, tumor board held with treatment decision, treatment review completed and start of treatment by 21 days post biopsy/surgical resection date, and then completion of 1 cycle of therapy."
次要结局
- Number of Participants With Adverse Events as a Measure of Safety(Adverse Events were collected starting with the date of the first dose of study drug until 30 days after last dose of study drug, ongoing related adverse events were continued to be followed until resolution, on average of 3 years.)
- Overall Response Rate (ORR) of Participants by the Presence of Radiologically Assessable Disease by Cross-sectional CT or MRI Imaging and/or by MIBG or PET Scans.(Followed until off therapy, generally 3 years)
研究者
Giselle Sholler
Beat Childhood Cancer Chair
Milton S. Hershey Medical Center
研究点 (26)
Loading locations...
相似试验
已完成
不适用
Molecular Guided Therapy for Refractory or Recurrent NeuroblastomaNeuroblastomaNCT01355679Giselle Sholler16
已完成
不适用
Molecular-Guided Therapy for Childhood CancerCraniopharyngiomaMedulloblastomaChoroid Plexus NeoplasmsGliomaDysembryoplastic Neuroepithelial TumorPrimitive Neuroectodermal Tumors (PNETs)Germ Cell TumorsNon-rhabdomyosarcomaEwings SarcomaRhabdomyosarcomaOsteosarcomaWilms TumorMalignant Rhabdoid TumorClear Cell SarcomaLiver TumorsRenal Cell CarcinomaNeuroblastomaMeningiomaEpendymomaNCT02162732Giselle Sholler186
已完成
不适用
iTBS rTMS in Mild Cognitive ImpairmentMild Cognitive ImpairmentNCT05327257Maria I. Lapid, M.D.25
已完成
不适用
New Treatment Algorithm to Reduce Spherical Aberration After LASIK Correction for MyopiaMyopiaAstigmatismNCT01988415Abbott Medical Optics26
已完成
不适用
A Trial Using Molecular-Guided Therapy in Patients With Refractory or Recurrent NeuroblastomaRefractory NeuroblastomaRelapsed NeuroblastomaNCT01109238Giselle Sholler5