Phase I/II a Study of Decitabine in Combination With Genistein in Pediatric Relapsed or Refractory Malignancies
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|ClinicalTrials.gov Identifier: NCT02499861|
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : November 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Decitabine and Genistein||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IIa Study of Decitabine in Combination With Genistein in Pediatric Patients With Relapsed or Refractory Solid Tumors and Leukemia|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||October 24, 2017|
|Actual Study Completion Date :||October 24, 2017|
Experimental: Decitabine and Genistein
continuous 24 hours Intravenous decitabine followed by oral genistein for 20 days.
Drug: Decitabine and Genistein
intravenous Decitabine with oral genistein
- Maximum tolerated dose of the combination of intravenous decitabine with oral genistein for children with refractory or recurrent solid malignancies and leukemia [ Time Frame: 12-18 mnths ]
- Number of participants with adverse events as a measurement of safety and tolerability of the combination of intravenous decitabine with oral genistein in children. [ Time Frame: 12-18 months ]
- Clinical benefit of the combination of intravenous decitabine with oral genistein in phase IIa of the study measure by either volumetric MRI for solid tumor or by bone marrow aspiration or biopsy for leukemia) at the end of cycle 2, 4, 6, 9 and 12. [ Time Frame: 42 months ]
- Plasma concentration of decitabine and genistein during cycle 1 and 2 (just in Phase I). [ Time Frame: 12-18 months ]
- DNA methylation levels in selected gene promoters before and after treatment. [ Time Frame: 42 months ]
- Quality of life assess through Peds Quality of Life Cancer module, Peds Quality of Life Fatigue module, Reported Health status 15-items, Pain Visual Analogue Scale, Distress Rating Scale, Expectations and McGill Quality of Life Questionnaire [ Time Frame: 42 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499861
|St. Justine's Hospital|
|Montreal, Quebec, Canada, H3T 1C5|
|Principal Investigator:||Henrique Bittencourt, MD||St. Justine's Hospital|