Phase II Study of Lapatinib in Children and Adults With Neurofibromatosis Type 2(NF2) and NF2-related Tumors
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the objective response rates to Lapatinib in patients with NF2-related tumors including cranial nerve schwannomas, meningiomas and ependymomas.
Every three months for one year
Matthias A Karajannis, MD, MS
NYU School of Medicine
United States: Institutional Review Board
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