Key Inclusion Criteria:
- Age:12 Months to 21 Years
- Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
- Patients must have either measurable or evaluable disease
- Standard COG Phase 1 organ function requirements.
- Cardiac function: Shortening fraction of >= 27% by echocardiogram, or Ejection fraction of >= 50% by gated radionuclide study. No supraventricular arrhythmia on electrocardiogram (EKG). Prolonged rate corrected QT (QTc) interval < 500 msec.
Key Exclusion Criteria:
- Patients with uncontrolled high blood pressure (i.e., systolic blood pressure > 99th percentile) are not eligible.
- Patients with known cardiopulmonary disease are not eligible.
- Patients with known hepatic cirrhosis or severe pre-existing hepatic impairment are not eligible.
- Patients with uncontrolled coagulopathy or bleeding disorder are not eligible.
- Patients must not have received enzyme-inducing anticonvulsants for at least 7 days prior to enrollment.
- Patients who have received drugs that are strong or moderate inhibitors and/or inducers of CYP3A4 within 14 days prior to enrollment are not eligible; while on study, the following BCRP inhibitors (cyclosporine, eltrombopag, gefitinib) should be avoided if possible, and concomitant use of UGT1A1 inhibitors, such as diclofenac, ketoconazole, probenecid, silibinin, nilotinib and atazanavir, should be avoided because of potential for increased irinotecan toxicity.
Patients with known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection are not eligible.