ADVL0912: A Phase I/II study of PF-02341066, an Oral Small Molecule Inhibitor of Anaplastic Lymphoma Kinase (ALK) and c-MET, in children with Relapsed/Refractory Solid Tumors, Primary CNS Tumors, and Anaplastic Large Cell Lymphoma
What is the purpose of this study?
This phase I/II trial is studying the side effects and best dose of crizotinib and to see how well it works in treating young patients with relapsed or refractory solid tumors or anaplastic large cell lymphoma.
- Cancer - Brain and Spinal Tumors
- Cancer - Kidney Tumors
- Cancer - Leukemia and Lymphoma
- Cancer - Liver Tumors
- Cancer - Musculoskeletal Tumors
- Cancer - Neuroblastoma
- Cancer - Retinoblastoma
What is involved?
This is a multicenter, phase I dose-escalation study followed by a phase II study.
Patients receive oral crizotinib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Plasma and whole blood samples are collected for pharmacokinetic and pharmacogenomic analysis. Tumor tissue (from patients with neuroblastoma) and bone marrow and/or peripheral blood (from patients with anaplastic large cell lymphoma) samples are collected for further correlative laboratory studies.
After completion of study treatment, patients are followed up periodically.
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?