Refractory Malignant Solid Neoplasm Clinical Trial
Official title:
A Phase 1/2 Study of Crizotinib, an Oral Small Molecule Inhibitor of Anaplastic Lymphoma Kinase (ALK) and C-Met, in Children With Relapsed/Refractory Solid Tumors and Anaplastic Large Cell Lymphoma
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)
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.
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