COZMOS:Phase I/Ib Trial of Combined 5'Azacitidine and Carboplatin for Recurrent/Refractory Pediat… (NCT03206021) | Clinical Trial Compass
CompletedPhase 1
COZMOS:Phase I/Ib Trial of Combined 5'Azacitidine and Carboplatin for Recurrent/Refractory Pediatric Brain/Solid Tumors
United States, Australia31 participantsStarted 2017-08-01
Plain-language summary
Many pediatric brain and solid tumors have altered epigenetic landscapes, and altered DNA methylation. As such this study is a Phase I/Ib study of combined 5'Azacitidine with an escalating dose of carboplatin for all recurrent/refractory pediatric brain and solid tumors. The phase I component will establish with maximum tolerated dose of carboplatin with azacytidine. An expansion cohort will be recruited of up to 30 patients will follow consisting of 20 recurrent posterior fossa ependymoma and 10 recurrent supratentorial ependymoma.
Who can participate
Age range1 Year – 18 Years
SexALL
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Inclusion criteria
✓. Greater than the age of 1 year and under age 18 at the time of study enrolment
✓. Recurrent or refractory brain or solid tumor, including recurrent or refractory ependymoma
✓. Tissue from diagnosis or resection prior to registration must be available (either flash frozen tissue or an FFPE block)
✓. Previous therapy with carboplatin will be permitted
✓. Failed first line treatment (surgery, radiation therapy or chemotherapy) and should not be eligible for treatment with curative potential.
✓. Be at least 4 weeks from the completion of myelosuppressive chemotherapy and/or biologic agents before starting day 1 of this study treatment
✓. Be at least 14 days from the completion of radiation therapy and MIBG before starting day 1 of this study treatment
✓. Be at least 3 months post hematopoetic stem cell rescue following myeloablative therapy before starting day 1 of this study treatment
Exclusion criteria
What they're measuring
1
Establish maximum tolerated dose of carboplatin in combination with 5'azacytidine
. Female patient who is pregnant or breast feeding (Lactating females must agree not to breast feed while taking azacitidine) or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 6 months after the end of study treatment.
✕. Patients may not be receiving any other investigational agents within 30 days prior to day 1 of protocol treatment
✕. Prior therapy with a DNA demethylase inhibitor
✕. Evidence of cardiac toxicity (shortening fraction below 28%; shortening fraction measures and ratios the change in the diameter of the left ventricle between the contracted and relaxed states)