Clinical Trials Office

ADVL1011: A Phase I Study of JAK Inhibition (INCB018424) in Children With Relapsed or Refractory Solid Tumors, Leukemias, and Myeloproliferative Neoplasms

What is the purpose of this study?

This phase I clinical trial is studying the side effects and best dose of INCB18424 in treating young patients with relapsed or refractory solid tumor, leukemia, or myeloproliferative disease.

Who can participate?

  • Karnofsky performance status (PS) 50-100% (for patients > 16 years old) or Lansky PS 50-100% (for patients ≤ 16 years old)
    • Patients who are unable to walk because of paralysis, but who can actively sit up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance status
  • Patients with solid tumors* must meet the following criteria:
    • Peripheral ANC ≥ 1,000/mm^3
    • Platelet count ≥ 100,000/mm^3 (transfusion-independent, defined as > 7 days since prior platelet transfusions)
    • Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
      • Not refractory to to red cell or platelet transfusion
    • ALT ≤ 110 U/L NOTE: *Patients with solid tumors and known bone marrow metastatic disease are eligible for study, but not evaluable for hematologic toxicity. These patients must not be known to be refractory to RBC or platelet transfusions.
  • Patients with leukemia or MPNs must meet the following criteria:
    • Platelet count ≥ 20,000/mm^3 (may receive platelet infusions)
    • Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
    • ALT ≤ 225 U/L
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
    • ≤ 0.6 mg/dL (for patients 1 to < 2 years old)
    • ≤ 0.8 mg/dL (for patients 2 to < 6 years old)
    • ≤ 1 mg/dL (for patients 6 to < 10 years old)
    • ≤ 1.2 mg/dL (for patients 10 to < 13 years old)
    • ≤ 1.4 mg/dL (for female patients ≥ 13 years old)
    • ≤ 1.5 mg/dL (for male patients 13 to < 16 years old)
    • ≤ 1.7 mg/dL (for male patients ≥ 16 years old)
  • Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 times upper limit of normal for age
  • Serum albumin ≥ 2 g/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to swallow crushed or whole tablets
    • Nasogastric or G tube administration is not allowed
  • Body surface area ≥ 0.65 m^2 (for patients at dose level -1, 1, and 2)
  • No uncontrolled infection, including patients with known active HIV or chronic hepatitis
  • No patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Ages

  • From 1 To 21  years old

Conditions

  • Cancer - Brain and Spinal Tumors
  • Cancer - Hemangioma and Vascular Malformation
  • Cancer - Leukemia and Lymphoma
  • Cancer - Liver Tumors
  • Cancer - Musculoskeletal Tumors
  • Cancer - Neuroblastoma
  • Cancer - Retinoblastoma

Who should I contact for more information?

Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org

Where can I find additional information?