Phase I/II a Study of Decitabine in Combination With Genistein in Pediatric Relapsed or Refractory Malignancies

Summary

This Phase I/IIa study will test the combination of the epigenetic drug decitabine with the isoflavone genistein in children with leukemias and solid tumors. For the phase I study, the maximum tolerated dose will be evaluated in pediatric patients with relapsed or refractory leukemia and solid tumors. For the phase II study, only patients with relapsed or refractory leukemias will be included. To further evaluate the treatment efficacy and gain further insight into action of these drugs, the DNA methylation levels before and after treatment for all participants, pharmacokinetics parameters such as through level for decitabine and through and peak level for genistein will be measured. Pharmacogenomics testing for decitabine will be performed prior to cycle 1 of treatment. Decitabine will be administered over a 24 hours infusion on day 1 of cycle (28 days) and genistein will be taken orally twice daily from day 2 to 21, followed by a 7 days rest period.

Timeline

Start

2015-07

Primary completion

2017-10-24

Completion

2017-10-24

Drugs

Indications