Dose-Escalation Study of Pixantrone Monotherapy in Pediatric Patients With Relapsed or Refractory Cancer

Inclusion criteria

• ✓. Patient and/or guardian have signed an Informed Consent Form and Assent approved by the Institutional Review Board or Institutional Ethics Committee, as appropriate and necessary, on a per-age basis
• ✓. Age 6 months to 21 years old (initial qualifying diagnosis must have been made at or before the age of 18 and the patient must be under the care of a pediatric hematologist/oncologist)
• ✓. Patient received a diagnosis of lymphoma or any non-hematologic malignancy (except central nervous system \[CNS\] tumors) for which the patient is considered relapsed or refractory. (NOTE: CNS metastases are allowable in patients who are deemed not at risk for progression during the first 30 days, who are neurologically stable, and, if on corticosteroids, have been on a stable corticosteroid dose for at least 2 weeks.) Patients who have \>1 malignancy ongoing during screening are not eligible
• ✓. Patient must have one or more of the following treatment statuses:
• ✓. In dose-escalation accrual, patients may have un-measurable disease (such as bone marrow/bone involvement or diffuse tumors)
• ✓. In dose-escalation accrual, patients may have un-measurable disease in cases where the standard of care would indicate the need for adjuvant chemotherapy after definitive surgery or radiation, but for whom no standard chemotherapy options are available
• ✓. In expansion cohort accrual, patients must have disease that is evaluable or measurable for response and progression per standard criteria for their diagnosis (Refer to the Appendices: RECIST 1.1 Criteria for Evaluation of Solid Tumors, Including Neuroblastoma, Appendix 18.4\], Evaluation of Neuroblastoma \[Appendix 18.6\], and the Lymphoma Staging and Disease Response Criteria \[Appendix 18.5\])
• ✓. Karnofsky-Lansky performance status (as per age of patient) ≥50 (Appendix 18.1)

Exclusion criteria