9-ING-41 in Pediatric Patients With Refractory Malignancies.

Inclusion criteria

• ✓. Age \< 22 years of age
• ✓. Diagnosis of recurrent or refractory malignancy with histologic verification of malignancy at original diagnosis or relapse, except patients with extra-cranial germ-cell tumors who have elevations of serum tumor markers including alpha-fetoprotein or beta-HCG, and/or patients with intrinsic brain stem tumors or patients with CNS-germ cell tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or beta-HCG.
• ✓. Have either measurable or evaluable disease. Evaluable disease is defined as an assessment of tumor that cannot be measured using a ruler or calipers, but can be used to determine disease progression or response (e.g., positive lesions on MIBG or bone scan, metastatic bone marrow disease, elevated tumor markers, or presence of a malignant pleural effusion)
• ✓. Have current disease state for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
• ✓. Have Performance Level: Karnofsky ≥ 50% for patients \>16 years of age and Lansky ≥50 for patients ≤16 years of age
• ✓. Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Patients with CNS tumors who are receiving steroids must be on a stable or decreasing dose for at least 7 days prior to study entry. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• ✓. Have fully recovered from the acute clinically significant toxic effects of prior anti-cancer therapy
• ✓. Have received at least one front line treatment regimen for the treatment of their malignancy - on the Irinotecan combination arm, patients may have received prior Irinotecan

Exclusion criteria