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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00939770 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 Type: | Interventional |
| Study Design: | 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 |
| Estimated Enrollment: | 196 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* malignancy at original diagnosis or relapse, including the following:
CNS tumors (phase I)
Anaplastic large cell lymphoma (ALCL) (phase I or II)
Measurable and/or evaluable disease
PATIENT CHARACTERISTICS:
Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) or Lansky PS 50-100% (for patients ≤ 16 years of age)
Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
PRIOR CONCURRENT THERAPY:
At least 3 months since prior bone marrow or stem cell transplant (without TBI) (≥ 6 weeks for patients with neuroblastoma or patients with confirmed ALK fusion proteins, ALK mutations, or ALK amplification)
At least 14 days since prior cytotoxic therapy for patients with ALCL who relapse while receiving cytotoxic therapy
Contacts and Locations
Show 26 Study Locations| Study Chair: | Yael P. Mosse, MD | Children's Hospital of Philadelphia |
More Information
| Responsible Party: | Susan M. Blaney, Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00939770 History of Changes |
| Obsolete Identifiers: | NCT01182896 |
| Other Study ID Numbers: | CDR0000647587, COG-ADVL0912 |
| Study First Received: | July 14, 2009 |
| Last Updated: | May 23, 2012 |
| Health Authority: | Unspecified |
|
unspecified childhood solid tumor, protocol specific recurrent neuroblastoma recurrent childhood anaplastic large cell lymphoma recurrent childhood brain stem glioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood anaplastic astrocytoma recurrent childhood anaplastic oligoastrocytoma recurrent childhood anaplastic oligodendroglioma recurrent childhood fibrillary astrocytoma recurrent childhood gemistocytic astrocytoma recurrent childhood giant cell glioblastoma recurrent childhood glioblastoma recurrent childhood gliomatosis cerebri recurrent childhood gliosarcoma |
recurrent childhood oligoastrocytoma recurrent childhood oligodendroglioma recurrent childhood pilocytic astrocytoma recurrent childhood pilomyxoid astrocytoma recurrent childhood pleomorphic xanthoastrocytoma recurrent childhood protoplasmic astrocytoma recurrent childhood subependymal giant cell astrocytoma recurrent childhood visual pathway and hypothalamic glioma recurrent childhood visual pathway glioma recurrent childhood medulloblastoma recurrent childhood ependymoma recurrent childhood pineoblastoma recurrent childhood supratentorial primitive neuroectodermal tumor childhood choroid plexus tumor childhood craniopharyngioma |
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Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Nervous System Neoplasms Neuroblastoma Central Nervous System Neoplasms Lymphoma, Large-Cell, Anaplastic Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, B-Cell Neoplasms by Site Nervous System Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Lymphoma, T-Cell |