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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00939770 |
RATIONALE: PF-02341066 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 PF-02341066 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 |
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Brain and Central Nervous System Tumors Lymphoma Neuroblastoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: MET tyrosine kinase inhibitor PF-02341066 Other: pharmacogenomic studies Other: pharmacological study |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | 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: | 112 |
Study Start Date: | May 2009 |
Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral MET tyrosine kinase inhibitor PF-02341066 twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses 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.
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 6 months since prior total-body radiotherapy (TBI), craniospinal radiotherapy, or radiotherapy to
At least 14 days since prior cytotoxic therapy for patients with ALCL who relapse while receiving cytotoxic therapy
Responsible Party: | Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital ( Susan M. Blaney ) |
Study ID Numbers: | CDR0000647587, COG-ADVL0912 |
Study First Received: | July 14, 2009 |
Last Updated: | July 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00939770 History of Changes |
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 childhood choroid plexus tumor childhood craniopharyngioma childhood ependymoblastoma recurrent childhood medulloblastoma childhood medulloepithelioma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood ependymoma childhood grade I meningioma childhood grade II meningioma |
childhood grade III meningioma childhood mixed glioma childhood oligodendroglioma recurrent childhood pineoblastoma recurrent childhood subependymal giant cell astrocytoma recurrent childhood visual pathway and hypothalamic glioma childhood central nervous system germ cell tumor recurrent childhood spinal cord neoplasm childhood infratentorial ependymoma childhood supratentorial ependymoma childhood high-grade cerebellar astrocytoma childhood high-grade cerebral astrocytoma childhood low-grade cerebellar astrocytoma childhood low-grade cerebral astrocytoma childhood atypical teratoid/rhabdoid tumor |
Choroid Plexus Neoplasms Rhabdoid Tumor Neuroectodermal Tumors, Primitive Tyrosine Central Nervous System Neoplasms Neuroblastoma Ependymoma Lymphoma, B-Cell Lymphoma, T-Cell Neoplasms, Germ Cell and Embryonal Lymphoma, Large-Cell, Anaplastic Craniopharyngioma Neuroepithelioma Meningioma Glioma |
Lymphoma, Large-cell Lymphoma Nervous System Neoplasms Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Astrocytoma Spinal Cord Neoplasm Recurrence Neuroectodermal Tumors Lymphatic Diseases Brain Stem Glioma, Childhood B-cell Lymphomas Medulloblastoma Spinal Cord Neoplasms Oligodendroglioma |
Lymphoma, Large B-Cell, Diffuse Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Neoplasms Neuroblastoma Lymphoma, B-Cell Neuroectodermal Tumors Lymphatic Diseases |
Neoplasms Neoplasms by Site Lymphoma, T-Cell Neoplasms, Germ Cell and Embryonal Lymphoma, Large-Cell, Anaplastic Neoplasms, Neuroepithelial Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Neuroectodermal Tumors, Primitive, Peripheral Nervous System Neoplasms Neoplasms, Glandular and Epithelial |