|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | New York University School of Medicine |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00973739 |
Purpose
The purpose of this study is to determine if Lapatinib has any effect on tumors found in patients with Neurofibromatosis Type 2 (NF2). NF2 is a condition that mainly affects the skin and nervous system. It causes non-cancerous tumors (which are known as neuromas) to grow on the nerves around a person's body. Some signs of NF2 include a gradual loss of hearing and tumors growing on the skin, the brain and the spinal cord which can lead to complications.
Lapatinib is an oral drug that is approved by Food and Drug Administration (FDA) for other types of tumors, it is not approved by the FDA for treatment of NF2 related tumors. The investigators know a lot about how well it is tolerated, but the investigators do not know if it is effective in treating your condition, therefore it is considered to be an investigational medication. This study will test whether Lapatinib may shrink tumors commonly found in patients with NF2 or stop them from growing. This will help us to decide if Lapatinib should be used to treat NF2 patients in future. Lapatinib is a drug that has been used for over 10 years to treat various forms of cancer. It has not been studied for the treatment of tumors in NF2 patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Neurofibromatosis 2 Vestibular Schwannoma |
Drug: Lapatinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Study of Lapatinib in Children and Adults With Neurofibromatosis Type 2(NF2) and NF2-related Tumors |
| Estimated Enrollment: | 17 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Lapatinib is dosed according to age. Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment.
Children/adolescents (<18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO (3 tablets twice daily)
Adults (>=18 years of age): 1,500 mg PO (6 tablets once daily)
Duration: Up to 12 months, depending on treatment response.
In this trial, we propose to assess the objective response rates to Lapatinib in patients with NF2-related tumors. Lapatinib is a commercially available inhibitor of ErbB2 and EGF. Data suggests that abnormal signaling via EGFR and ErbB2 is a major contributor to tumor growth and progression in both sporadic and NF2-related VS and that inhibition of this signaling pathway can result in decreased tumor growth.
Demonstrating that Lapatinib produces an objective response to reduce tumor volume or stabilize disease will provide additional treatment options for NF patients with multiple tumor growth. For patients with VS we expect to see ≥ 10 dB improvement in PTA and/or improvement in SDS, compared to the audiogram at initiation of treatment. Currently there are no available treatment options for NF2 patients with multiple tumors. Depending on tumor cell type, lapatinib has cytostatic or cytotoxic antitumor effects, and in a recent study assessing the biological effects of Lapatinib on the associated molecular pathways and tumor growth in patients with solid tumors, a correlation was seen between tumor response and pre-treatment levels of (phosphor)-ErbB2 and (phosphor)-ERK1/2.
Eligibility| Ages Eligible for Study: | 4 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Matthais A Karajannis, MD, MS | 212-263-9959 | matthias.karajannis@nyumc.org |
| Contact: Iyore Ayanru, B.A. | 212-263-9945 | osato.ayanru@nyumc.org |
| United States, New York | |
| New York University School of Medicine | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Iyore Ayanru, BA 212-263-9945 Osato.Ayanru@nyumc.org | |
| Sub-Investigator: Jeffrey Allen, MD | |
| Sub-Investigator: Sharon Gardner, M.D. | |
| Sub-Investigator: John T Golfinos, M.D. | |
| Sub-Investigator: Pamela Roehm, M.D., PhD | |
| Sub-Investigator: Annette Nusbaum, MD | |
| Sub-Investigator: Mari Hagiwara, MD | |
| Sub-Investigator: John T Roland, MD | |
| Sub-Investigator: Mark Ballas, MD, MPH | |
| Principal Investigator: | Matthias A Karajannis, MD, MS | NYU School of Medicine |
More Information
| Responsible Party: | New York University School of Medicine ( Matthias A. Karajannis, M.D./ Assistant Professor of Pediatrics ) |
| Study ID Numbers: | 09-0328 |
| Study First Received: | September 3, 2009 |
| Last Updated: | September 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00973739 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
NF-2 NF-2 related tumors Schwannoma, Acoustic, Bilateral schwannomas Neurilemmoma of other cranial and peripheral nerves |
NF2 related benign intracranial tumors including NF2 related meningiomas NF2 related ependymomas NF2 related spinal neurofibromas NF2 related gliomas |
|
Vestibulocochlear Nerve Diseases Otorhinolaryngologic Neoplasms Molecular Mechanisms of Pharmacological Action Neuroma, Acoustic Antineoplastic Agents Retrocochlear Diseases Neoplasms, Nerve Tissue Cranial Nerve Neoplasms Neurodegenerative Diseases Protein Kinase Inhibitors Ear Diseases Neurofibromatosis 1 Neurofibromatosis 2 Heredodegenerative Disorders, Nervous System Neoplasms by Site |
Neuromuscular Diseases Neurofibroma Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nervous System Neoplasms Neurocutaneous Syndromes Otorhinolaryngologic Diseases Neoplasms by Histologic Type Nervous System Diseases Neurilemmoma Enzyme Inhibitors Lapatinib Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors |