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Sponsors and Collaborators: |
Pediatric Brain Tumor Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00095940 |
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying lapatinib to see how well it works in treating young patients with recurrent or refractory CNS tumors.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: lapatinib ditosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Molecular Biology And Phase II Study Of Lapatinib (GW572016) In Pediatric Patients With Recurrent Or Refractory Medulloblastoma, Malignant Glioma Or Ependymoma |
Estimated Enrollment: | 84 |
Study Start Date: | January 2005 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to histology (medulloblastoma/primitive neuroectodermal tumor vs high-grade glioma vs ependymoma).
Patients receive oral lapatinib twice daily on days 1-28. Treatment repeats every 28 days for up to 26 courses (2 years) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for at least 30 days.
PROJECTED ACCRUAL: A total 84 patients will be accrued for this study.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010-2970 | |
United States, Illinois | |
Children's Memorial Hospital - Chicago | |
Chicago, Illinois, United States, 60614 | |
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, 02115 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104-4318 | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 | |
United States, Texas | |
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | |
Houston, Texas, United States, 77030-2399 | |
United States, Washington | |
Children's Hospital and Regional Medical Center - Seattle | |
Seattle, Washington, United States, 98105 |
Study Chair: | Maryam Fouladi, MD | Children's Hospital Medical Center, Cincinnati |
Investigator: | Richard J. Gilbertson, MD, PhD | St. Jude Children's Research Hospital |
Responsible Party: | St. Jude Children's Research Hospital ( James M. Boyett ) |
Study ID Numbers: | CDR0000393490, PBTC-016 |
Study First Received: | November 9, 2004 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00095940 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent childhood medulloblastoma recurrent childhood ependymoma childhood central nervous system germ cell tumor childhood choroid plexus tumor childhood craniopharyngioma childhood infratentorial ependymoma childhood grade III meningioma childhood oligodendroglioma childhood spinal cord neoplasm |
childhood supratentorial ependymoma childhood high-grade cerebral astrocytoma childhood low-grade cerebral astrocytoma recurrent childhood brain stem glioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood visual pathway and hypothalamic glioma |
Choroid Plexus Neoplasms Neuroectodermal Tumors, Primitive Astrocytoma Spinal Cord Neoplasm Lapatinib Central Nervous System Neoplasms Protein Kinase Inhibitors Recurrence Ependymoma Neuroectodermal Tumors Brain Stem Glioma, Childhood |
Neoplasms, Germ Cell and Embryonal Medulloblastoma Craniopharyngioma Neuroepithelioma Spinal Cord Neoplasms Oligodendroglioma Meningioma Glioma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Neoplasms, Nerve Tissue Enzyme Inhibitors Lapatinib Central Nervous System Neoplasms Protein Kinase Inhibitors Pharmacologic Actions |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Medulloblastoma Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |