A Study of Nilotinib in Growing Vestibular Schwannomas

NCT01201538 | Terminated Phase 2

• 1 other identifier: OZM-024
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

Acoustic Neuromas (otherwise known as Vestibular Schwannoma -VS) are benign tumors which grow on the hearing nerve and can cause progressive hearing loss and compression of vital brain structures and even death if it continues. The primary objective of this study is to evaluate the efficacy of Nilotinib in the treatment of patients with progressing VS. Secondary objectives of this study is to evaluate the toxicity profile, quality of life and symptom management of Nilotinib in the treatment of patients with progressing VS.

Conditions

Growing Vestibular Schwannomas

Outcome Measures

Primary Outcomes (1)

• volume change of Vestibular Schwannoma

  Primary Outcomes of interest will be volumetric tumor response and lack of tumor progression. A response to treatment will be defined as a 20% or greater, change in volume, as defined by Plotkin et al.

  3 years - 1 year drug treatment, 2 year follow-up

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: Nilotinib

Interventions

Nilotinib DRUG

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years of age with either sporadic or NF-2 associated VS
• Growing VS defined as an increase in MRI volumetric growth (minimal 15%) on two successive scans within 18 months prior to registration
• Patients may be either treatment naïve or have recurrent VS after previous surgery/ stereotactic radiosurgery
• Essentially neurologically asymptomatic (with the exception of sensorineural hearing loss, mild tinnitus and facial numbness) as assessed by the investigator
• Karnofsky performance score \>70
• Adequate renal, haematological, liver function within 7 days prior to registration
• Willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions
• Willingness and ability to provide informed consent

You may not qualify if:

• Brain stem compression with symptoms
• Symptomatic hydrocephalus
• T2/Flair signal changes with distortion of adjacent brain stem and IVth ventricle
• Lower cranial nerve dysfunction
• Concurrent or previous invasive malignancy, except adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for ≥ 3 years
• Evidence of severe or uncontrolled systemic disease which in the opinion of the investigator makes it undesirable for the subject to participate in the study
• Known hypersensitivity to the study drug or drug of similar chemical or biological composition
• Impaired cardiac function including
• Congenital long QT syndrome or family history of long QT syndrome
• Clinically significant resting bradycardia (\< 50 beats per minute)
• Myocardial infarction within 1 year prior to registration or other clinically significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension)
• History of or current clinically significant ventricular or atrial tachyarrhythmia
• QTcF \> 450 msec on screening ECG. If QTcF \> 450 msec and electrolytes are not within normal ranges then electrolytes should be corrected and the patient rescreened for QTcF.
• Unable to monitor the QT/QTc interval on ECG
• Treatment with strong CYP3A4 inhibitors or CYP3A4 inducers and treatment cannot be either discontinued or switched to a different medication prior to starting study drug.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Novartis: collaborator

Study Sites (2)

Toronto Western Hospital

Toronto, Ontario, m5t 2s8, Canada

Location

University Health Network

Toronto, Ontario, m5t 2s8, Canada

Location

MeSH Terms

Interventions

nilotinib

Study Officials

• Abhijit Guha

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 14, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2013
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

CA (2)