NCT03581240Available不适用
An Intermediate Expanded Use Trial of DFMO
Giselle Sholler1 个研究点 分布在 1 个国家开始时间: 2018年7月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
- 发起方
- 试验地点
- 1
研究概览
简要总结
To provide DFMO in an expanded use setting to subjects with relapsed rare tumors with increased LIN28 expression or MYCN amplification or up regulation of ornithine decarboxylase.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 0 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 0-30 years at the time of initial diagnosis.
- •Diagnosis: Histologic verification at either the time of original diagnosis or a previous relapse of High Risk neuroblastoma, medulloblastoma, atypical teratoid rhabdoid tumor, embryonal tumor with abundant neuropil and true rosettes, ependymoblastoma, medulloepithelioma and other rare pediatric MYC, ODC or LIN28/Let7 driven tumors (each type will form a new subset).
- •Disease Status: Subjects must be in one of the following disease categories:
- •High risk neuroblastoma patients that have completed standard of care upfront therapy and are not eligible for NMTRC
- •Medulloblastoma patients who have completed standard of care therapies.
- •Relapsed/refractory neuroblastoma patients who have completed standard of care therapies.
- •Rare tumors with increased LIN28 expression or MYCN amplification or up regulation of ornithine decarboxylase who have completed standard of care therapies.
- •Subjects are not eligible to enroll on DFMO studies NMTRC002, NMTRC003, NMTRC010, or NMTRC
- •A negative serum or urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ≥13 years of age).
- •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
排除标准
- •BSA (m2) of <0.25
- •Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
研究者
Giselle Sholler
Study Chair
Milton S. Hershey Medical Center
研究点 (1)
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