Phase I/II a Study of Decitabine in Combination With Genistein in Pediatric Relapsed or Refractory Malignancies
Status:
Completed
Trial end date:
2017-10-24
Target enrollment:
Participant gender:
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.