Clinical Trial: Crizotinib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
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
Brief Summary:
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.
Detailed Summary:
OBJECTIVES:
Primary
- 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.
Secondary
- 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 ph
Sponsor: Children's Oncology Group
Current Primary Outcome:
- 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 ]
Original Primary Outcome:
- Maximum tolerated dose and recommended phase II dose of MET tyrosine kinase inhibitor PF-02341066 in children with relapsed or refractory solid tumors or anaplastic large cell lymphoma (ALCL)
- Toxicities of MET tyrosine kinase inhibitor PF-02341066
- Pharmacokinetics of MET tyrosine kinase inhibitor PF-02341066
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- Antitumor activity of MET tyrosine kinase inhibitor PF-02341066 in children with relapsed or refractory solid tumors or ALCL
- Antitumor activity of MET tyrosine kinase inhibitor PF-02341066 in children with relapsed or refractory neuroblastoma or ALCL
- Relationship between response to treatment and anaplastic lymphoma kinase gene status in children with relapsed or refractory neuroblastoma or ALCL
- Relationship between minimal residual disease status and clinical response to treatment in children with ALCL
Information By: Children's Oncology Group
Dates:
Date Received: July 14, 2009
Date Started: September 2009
Date Completion: May 2017
Last Updated: May 10, 2017
Last Verified: May 2017
