ADVL0816: A Phase I Study of Obatoclax (Pan Anti-Apoptotic BCL-2 Family Small Molecule Inhibitor), in Combination with Vincristine/ Doxorubicin/Dexrazoxane, in Children with Relapsed/Refractory Solid Tumors or Leukemia

Why are we doing this research?


  • Estimate the maximum-tolerated dose and/or recommended phase II dose of obatoclax mesylate in combination with vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane hydrochloride in pediatric patients with refractory solid tumors
  • Define and describe the toxicities of obatoclax mesylate in these patients


  • Preliminarily define the antitumor activity of obatoclax hydrochloride in patients with refractory or relapsed solid tumors or leukemias within the confines of a phase I study

Who can participate?


  • 6 months-21 years

Performance Status

  • Karnofsky performance status 50-100% (> 16 years of age
  • Lansky performance status 50-100% (≤16 years of age)


  •  ANC ≥1,000/mm^3 (stratum 1)
  • Platelet count ≥100,000/mm^3 (transfusion independent defined as ≥7 days since prior transfusion)(stratum 1)
  • Platelet count ≥20,000/mm^3 (may receive platelet transfusion) (stratum 2 and 3)
  • Hemoglobin ≥8.0 g/dL (may receive RBC transfusion)


  • Cancer - Brain and Spinal Tumors
  • Cancer - Leukemia and Lymphoma


  • Female
  • Male


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