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
Unspecified Childhood Solid Tumor, Protocol Specific
Other: pharmacogenomic studies
Other: pharmacological study
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]
- Toxicities of crizotinib [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
- Pharmacokinetics of crizotinib [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- Antitumor activity of crizotinib in children with relapsed or refractory solid tumors or ALCL [ Time Frame: Up to 30 days post treatment ] [ Designated as safety issue: No ]
- Antitumor activity of crizotinib in children with relapsed or refractory neuroblastoma or ALCL [ Time Frame: Up to 30 days post treatment ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Relationship between minimal residual disease status and clinical response to treatment in children with ALCL [ Time Frame: Up to 30 days post treatment ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Primary Completion Date:||May 2017 (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|
|UAB Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|Children's Hospital of Orange County|
|Orange, California, United States, 92868|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Colorado|
|Children's Hospital Colorado Center for Cancer and Blood Disorders|
|Aurora, Colorado, United States, 80045|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2970|
|United States, Georgia|
|AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Children's Memorial Hospital - Chicago|
|Chicago, Illinois, United States, 60611|
|United States, Indiana|
|Riley's Children Cancer Center at Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 2115|
|United States, Michigan|
|C.S. Mott Children's Hospital at University of Michigan Medical Center|
|Ann Arbor, Michigan, United States, 48109-0286|
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis|
|St. Louis, Missouri, United States, 63110|
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229-3039|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205-2696|
|United States, Oregon|
|Knight Cancer Institute at Oregon Health and Science University|
|Portland, Oregon, United States, 97239-3098|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Baylor University Medical Center - Houston|
|Houston, Texas, United States, 77030-2399|
|United States, Washington|
|Children's Hospital and Regional Medical Center - Seattle|
|Seattle, Washington, United States, 98105|
|United States, Wisconsin|
|Midwest Children's Cancer Center at 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|