Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT00973739
Phase
PHASE2
Status
Completed

Conditions

  • Neurofibromatosis 2
  • Vestibular Schwannoma

Eligibility Criteria

Sex
ALL
Age
4 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Lapatinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 30, 2009
Status verified
Feb 2016
Primary completion
Oct 31, 2012
Completion
Nov 30, 2012

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib
    Lapatinib PO dosed according to age: Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily Adults (18 years of age or older): 1,500 mg PO once daily 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.

Primary Outcome Measure

Estimated Volumetric Progression Free Survival at 12 Months [ Time Frame: Every three months for one year ]

Locations (1)

FacilityCityStateZIPSite coordinators
New York University School of MedicineNew YorkNew York10016-

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By research site
New York University School of Medicine· New York, NY

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