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

Inclusion criteria

• Age ≥ 2 years of age and < 21 years of age at time of study enrollment
• Able to swallow genistein or take it with a puree.
• Patients must have a diagnosis of recurrent or refractory solid tumors, including Central Nervous System tumors, lymphoma or leukemia for which standard curative measures do not exist or are no longer effective
• For solid tumors, patients must have either measurable or evaluable disease. For leukemia, patients must have > 5% blasts in the bone marrow.
• Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy.
• Performance level: Karnofsky ≥50% for patients ≥ 16 years of age or Lansky ≥ 50% for patients < 16 years of age
• Life expectancy at least one month
• Patients must have adequate bone-marrow function
• Patients must have normal organ as defined below: (total bilirubin ≤ 24microM/L), Amylase/pancreatic amylase≤1.5 × institutional upper limit of normal, Aspartate Aminotransferase (AST) /Alanine Aminotransferase (ALT) ≤2.5 × institutional upper limit of normal, creatinine clearance ≥60 mL/min/1.73 m2.

OR creatinine according to age/gender

• Nervous system disorders (CTCAE v4) resulting from prior therapy must be ≤ Grade 2
• Participants of child-bearing potential and men must agree to use adequate contraception for the duration of study treatment, and 4 months after completion of decitabine and genistein administration.
• All patients and/or their parents or legally authorized representatives must sign a written informed consent

Exclusion criteria

• Prior decitabine or genistein therapy.
• Patients who are receiving any other investigational agents.
• Nasogastric or gastrostomy (or equivalent) administration of genistein is not allowed.
• Patients with known exclusive non-measurable leptomeningeal disease at enrolment should be excluded from this clinical trial.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine and genistein.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (receiving antibiotics), symptomatic heart or lung disease, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or breast-feeding women are excluded from this study. All girls of child bearing potential must have a negative pregnant test prior to enrolment.
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.