Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00939770|
Recruitment Status : Completed
First Posted : July 15, 2009
Last Update Posted : February 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|ALK Fusion Protein Expression ALK Gene Amplification ALK Gene Mutation ALK Positive c-MET Gene Amplification MET Gene Mutation Recurrent Childhood Anaplastic Large Cell Lymphoma Recurrent Malignant Solid Neoplasm Recurrent Neuroblastoma Refractory Anaplastic Large Cell Lymphoma Refractory Malignant Solid Neoplasm Refractory Neuroblastoma||Drug: Crizotinib Other: Laboratory Biomarker Analysis Other: Pharmacological Study Other: Questionnaire Administration||Phase 1 Phase 2|
I. To estimate the maximum tolerated dose (MTD) and recommend a Phase 2 dose of PF-02341066 (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 PF-02341066 administered on this schedule.
III. To characterize the pharmacokinetics of PF-02341066 in children with refractory cancer.
I. To preliminarily define the anti-tumor activity of PF-02341066 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 PF-02341066 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 PF-02341066.
IV. To preliminarily examine the relationship between minimal residual disease (MRD) status and clinical response to PF-02341066 in patients with ALCL.
V. To use a questionnaire to gather preliminary information on the palatability of the oral solution formulation of PF-02341066.
VI. To evaluate for potential alterations in bone growth in pediatric patients.
OUTLINE: This is a phase I dose-escalation study (completed 2/15/13) followed by a phase II 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study of PF-02341066, 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|
|Actual Study Start Date :||September 21, 2009|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Experimental: Treatment (crizotinib)
Patients receive crizotinib PO BID on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Questionnaire Administration
- Maximum-tolerated dose and recommended phase II dose of crizotinib [ Time Frame: 28 days ]The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for adverse event (AE) reporting. The MTD/RP2D is defined as the maximum dose at which fewer than one-third of patients experience dose limiting toxicity.
- Incidence of toxicities of crizotinib [ Time Frame: Up to 30 days post-treatment ]The descriptions and grading scales found in the revised NCI CTCAE version 4.0 will be utilized for AE reporting.
- PK AUC [ Time Frame: Day 1 of course 1 ]Pharmacokinetics of crizotinib: Area under the plasma concentration (AUC).
- Antitumor activity of crizotinib in children with relapsed or refractory solid tumors or anaplastic large cell lymphoma (ALCL) [ Time Frame: Up to 8 years ]This study will use a minor modification of the (RECIST) Response Evaluation Criteria in Solid Tumors from the NCI for assessment of radiographic response.
- Antitumor activity of crizotinib in children with relapsed or refractory neuroblastoma or anaplastic large cell lymphoma (ALCL) [ Time Frame: Up to 8 years ]This study will use a minor modification of the RECIST from the NCI for assessment of radiographic response.
- Minimal residual disease (MRD) status [ Time Frame: Up to 8 years ]MRD status will be reported descriptively. The relationship between MRD status and clinical response to treatment will be examined in children with ALCL.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939770
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|Principal Investigator:||Yael P Mosse||COG Phase I Consortium|