Crizotinib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
RATIONALE: Crizotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: 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.
|Brain and Central Nervous System Tumors Lymphoma Neuroblastoma Unspecified Childhood Solid Tumor, Protocol Specific||Drug: crizotinib Other: pharmacogenomic studies Other: pharmacological study||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||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|
- Maximum-tolerated dose and recommended phase II dose of crizotinib in children with relapsed or refractory solid tumors or anaplastic large cell lymphoma (ALCL) [ Time Frame: 28 Days ]
- Toxicities of crizotinib [ Time Frame: Up to 30 days post-treatment ]
- Pharmacokinetics of crizotinib [ Time Frame: Day 1 ]
- Antitumor activity of crizotinib in children with relapsed or refractory solid tumors or ALCL [ Time Frame: Up to 30 days post treatment ]
- Antitumor activity of crizotinib in children with relapsed or refractory neuroblastoma or ALCL [ Time Frame: Up to 30 days post treatment ]
- Relationship between response to treatment and anaplastic lymphoma kinase gene status in children with relapsed or refractory neuroblastoma or ALCL [ Time Frame: Up to 30 days post treatment ]
- Relationship between minimal residual disease status and clinical response to treatment in children with ALCL [ Time Frame: Up to 30 days post treatment ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||May 2020|
|Estimated Primary Completion Date:||May 2020 (Final data collection date for primary outcome measure)|
|Experimental: Treatment (Crizotinib)||Drug: crizotinib Other: pharmacogenomic studies Other: pharmacological study|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939770
Hide Study Locations
|United States, Alabama|
|Children's Hospital of Alabama|
|Birmingham, Alabama, United States, 35233|
|University of Alabama at Birmingham Cancer Center|
|Birmingham, Alabama, United States, 35233|
|United States, California|
|Children's Hospital of Orange County|
|Orange, California, United States, 92868|
|UCSF Medical Center-Mission Bay|
|San Francisco, California, United States, 94158|
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, D.C., District of Columbia, United States, 20010|
|United States, Georgia|
|Children's Healthcare of Atlanta - Egleston|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Lurie Children's Hospital-Chicago|
|Chicago, Illinois, United States, 60611|
|United States, Indiana|
|Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, Michigan|
|C S Mott Children's Hospital|
|Ann Arbor, Michigan, United States, 48109|
|United States, Minnesota|
|University of Minnesota/Masonic Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Columbia University/Herbert Irving Cancer Center|
|New York, New York, United States, 10032|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15224|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Vanderbilt University/Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|UT Southwestern/Simmons Cancer Center-Dallas|
|Dallas, Texas, United States, 75390|
|Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Study Chair:||Yael P. Mosse, MD||Children's Hospital of Philadelphia|