NCT02499861

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

A Phase I/IIa Study of Decitabine in Combination With Genistein in Pediatric Patients With Relapsed or Refractory Solid Tumors and Leukemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: St. Justine's Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Decitabine and Genistein	intravenous Decitabine with oral genistein

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-10-24
• Completion: 2017-10-24
• First posted: 2015-07-16
• Last updated: 2017-11-17

Locations

1 site across 1 country: Canada