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
What is the purpose of this study?
- 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?
- 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)
- Adult Studies
- Cancer - Brain and Spinal Tumors
- Cancer - Leukemia and Lymphoma
Who should I contact for more information?
Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Where can I find additional information?