Mocetinostat With Vinorelbine in Children, Adolescents & Young Adults With Refractory and/or Recu⦠(NCT04299113) | Clinical Trial Compass
Active ā Not RecruitingPhase 1
Mocetinostat With Vinorelbine in Children, Adolescents & Young Adults With Refractory and/or Recurrent Rhabdomyosarcoma
United States38 participantsStarted 2020-05-14
Plain-language summary
This phase I trial studies the side effects and best dose of mocetinostat when given together with vinorelbine to see how well it works in treating children, adolescents, and young adults with rhabdomyosarcoma that has spread to nearby tissues or lymph nodes and cannot be removed by surgery (locally advanced unresectable) or has spread to other places in the body (metastatic), and does not respond to treatment (refractory) or has come back (relapsed). Mocetinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving mocetinostat and vinorelbine may work better in treating children, adolescents, and young adults with rhabdomyosarcoma compared to vinorelbine alone.
Who can participate
Age range13 Years
SexALL
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Inclusion Criteria:
* Willing and able to provide written Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent. For subjects \< 18 years of age, their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines
* Have histologically or cytological confirmed diagnosis of rhabdomyosarcoma with locally advanced/unresectable, metastatic, refractory or relapsed disease who have failed standard therapy and for whom no known curative therapy exists
* Measurable disease according to RECIST version 1.1
* Prior cancer therapy: Subjects may have received any number of prior therapy regimens. In the investigator's opinion, subjects must have tolerated prior cytotoxic therapies well and have adequate bone marrow reserve. At the time of treatment initiation, at least 3 weeks must have elapsed after prior cytotoxic chemotherapy. At least 7 days must have elapsed since completion of any prior non-cytotoxic cancer therapy and any associated AEs must have resolved
* Prior radiotherapy is allowed if \>= 2 weeks have elapsed for local palliative radiation therapy (XRT) (small port); \>= 6 months must have elapsed if prior total body irradiation, craniospinal XRT or if \> 50% radiation of the pelvis; \> 6 weeks must have elapsed if other substantial bone marrow radiation (defined per principal investigator's \[PI's\] discretion). Subjects who have received brain irradiatā¦
What they're measuring
1
To describe any dose-limiting toxicity (DLT)
Timeframe: 1 year
2
To determine the maximum tolerated dose (MTD) or highest protocol defined doses (in the absence of exceeding the MTD)