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
- To estimate the maximum-tolerated dose and recommended phase II dose of crizotinib
administered orally twice daily to children with relapsed or refractory solid tumors or
anaplastic large cell lymphoma (ALCL).
- To define and describe the toxicities of this drug when administered on this schedule.
- To characterize the pharmacokinetics of this drug in these patients.
- To preliminarily define the antitumor activity of this drug within the confines of a
phase I study.
- To obtain initial phase II data on the antitumor activity of this drug in children with
relapsed or refractory neuroblastoma or ALCL.
- To preliminarily examine the relationship between response to treatment and anaplastic
lymphoma kinase gene status (e.g., the presence of a mutation, duplication,
amplification, and/or translocation) in children with relapsed or refractory
neuroblastoma or ALCL.
- To preliminarily examine the relationship between minimal residual disease status and
clinical response to treatment in children with ALCL.
OUTLINE: 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
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.
Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose and recommended phase II dose of crizotinib in children with relapsed or refractory solid tumors or anaplastic large cell lymphoma (ALCL)
Yael P. Mosse, MD
Children's Hospital of Philadelphia
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Children's Hospital of Orange County||Orange, California 92668|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|Children's Hospital and Regional Medical Center - Seattle||Seattle, Washington 98105|
|Children's Memorial Hospital - Chicago||Chicago, Illinois 60614|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Midwest Children's Cancer Center at Children's Hospital of Wisconsin||Milwaukee, Wisconsin 53226|
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|Baylor University Medical Center - Houston||Houston, Texas 77030-2399|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus||Atlanta, Georgia 30322|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|C.S. Mott Children's Hospital at University of Michigan Medical Center||Ann Arbor, Michigan 48109-0286|
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center||New York, New York 10032|
|Nationwide Children's Hospital||Columbus, Ohio 43205-2696|
|Knight Cancer Institute at Oregon Health and Science University||Portland, Oregon 97239-3098|
|Children's Hospital of Pittsburgh of UPMC||Pittsburgh, Pennsylvania 15213|
|Riley's Children Cancer Center at Riley Hospital for Children||Indianapolis, Indiana 46202-5225|
|UAB Comprehensive Cancer Center||Birmingham, Alabama 35294|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|
|Children's Hospital Colorado Center for Cancer and Blood Disorders||Aurora, Colorado 80045|