Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
Condition: Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Neuroblastoma; Refractory Anaplastic Large Cell Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Neuroblastoma
MeSH terms: Lymphoma; Neoplasms; Lymphoma, Non-Hodgkin; Neuroblastoma; Lymphoma, Large-Cell, Anaplastic; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This phase 1/2 trial the studies side effects and best dose of crizotinib and to see how well
      it works in treating young patients with solid tumors or anaplastic large cell lymphoma that
      has returned after a period of improvement or does not respond to treatment. Crizotinib may
      stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
      (Phase 1 completed 2/15/13)
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate the maximum tolerated dose (MTD) and recommend a Phase 2 dose of Crizotinib
      administered orally twice daily to children with relapsed/refractory solid tumors and
      anaplastic large cell lymphoma (ALCL). (completed 2/15/13) II. To define and describe the
      toxicities of Crizotinib administered on this schedule.

      III. To characterize the pharmacokinetics of Crizotinib in children with refractory cancer.

      SECONDARY OBJECTIVES:

      I. To preliminarily define the anti-tumor activity of Crizotinib within the confines of a
      Phase 1 study. (completed 2/15/13) II. To obtain initial Phase 2 data on the anti-tumor
      activity of Crizotinib in children with relapsed/refractory neuroblastoma and ALCL.

      III. To preliminarily examine the relationship between anaplastic lymphoma kinase (ALK)
      status (e.g, the presence of a mutation, duplication, amplification, and/or translocation) in
      patients with neuroblastoma (NB) or ALCL and response to Crizotinib.

      IV. To preliminarily examine the relationship between minimal residual disease (MRD) status
      and clinical response to Crizotinib in patients with ALCL.

      V. To use a questionnaire to gather preliminary information on the palatability of the oral
      solution formulation of Crizotinib.

      VI. To evaluate for potential alterations in bone growth in pediatric patients.

      OUTLINE: This is a phase 1 dose-escalation study (completed 2/15/13) followed by a phase 2
      study.

      Patients receive crizotinib orally (PO) twice daily (BID) on days 1-28. Treatment repeats
      every 28 days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up periodically.
    

Intervention name(s): Crizotinib; Laboratory Biomarker Analysis; Pharmacological Study; Questionnaire Administration
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): Given PO; Correlative studies; Correlative studies; Ancillary studies
Other intervention name(s): MET Tyrosine Kinase Inhibitor PF-02341066; PF-02341066; PF-2341066; Xalkori
Intervention MeSH terms: Crizotinib; Tyrosine Protein Kinase Inhibitors
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment