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| Sponsor: | University Health Network, Toronto |
|---|---|
| Collaborator: |
Novartis |
| Information provided by: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01201538 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Volumetric Tumor Response and Lack of Tumor Progression Quality of Life of Patients on Nilotinib Versus Not |
Drug: Nilotinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Nilotinib in Growing Vestibular Schwannomas |
| Estimated Enrollment: | 90 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
UHN laboratory has demonstrated that targets of Imatinib (c-Kit and PDGFR-α and PDGFR-ß) are overexpressed and activated in both sporadic and NF2 VS.It has also been shown pre-clinically that Imatinib induced a reduction in proliferation and cell viability, with increased apoptosis, in HEI-193 human NF2-null VS cells.Nilotinib is a newer generation RTK inhibitor, with a similar target profile as Imatinib. It was designed by modifying the Imatinib molecule62, and has 30-fold increased potency compared to IImatinib43. In clinical studies of patients with CML or GIST resistant to Imatinib, Nilotinib has demonstrated efficacy with minimal toxicity. Nilotinib (Tasigna®, code number AMN107) was first approved in 2007 for use in Philadelphia chromosome positive CML in the chronic or accelerated phase in patients resistant or intolerant to prior therapy. Thus making Nilotinib an ideal drug to study in understanding its benefit in VS patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion
Exclusion
Impaired cardiac function including
Contacts and Locations| Contact: Abhijit Guha | 416-603-5740 | abhijit.guha@uhn.on.ca |
| Contact: Takyee Tung, B.Sc | 416-603-5800 ext 5578 |
| Canada, Ontario | |
| Toronto Western Hospital | Not yet recruiting |
| Toronto, Ontario, Canada, m5t 2s8 | |
| Contact: Abhijit Guha 416-603-5740 abhijit.guha@uhn.on.ca | |
| Contact: Takyee Tung 416-603-5800 ext 5578 ttung@uhnres.utoronto.ca | |
| Principal Investigator: Abhijit Guha | |
| Sub-Investigator: Kim Edelstein | |
| Sub-Investigator: Normand Laperriere | |
| Sub-Investigator: Gelareh Zadeh | |
| Sub-Investigator: Walter Kucharczyk | |
| Sub-Investigator: John Rutka | |
| University Health Network | Recruiting |
| Toronto, Ontario, Canada, m5t 2s8 | |
| Contact: Abhijit Guha 416-603-5740 abhijit.guha@uhn.on.ca | |
| Principal Investigator: | Abhijit Guha | University Health Network, Toronto |
More Information
| Responsible Party: | Dr. Abhijit Guha, University Health Network |
| ClinicalTrials.gov Identifier: | NCT01201538 History of Changes |
| Other Study ID Numbers: | OZM-024 |
| Study First Received: | September 13, 2010 |
| Last Updated: | June 9, 2011 |
| Health Authority: | Canada: Health Canada |
|
Neurilemmoma Neuroma, Acoustic Neoplastic Processes Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Neuroma Peripheral Nervous System Neoplasms Nervous System Neoplasms |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Neoplasms by Site Cranial Nerve Neoplasms Vestibulocochlear Nerve Diseases Retrocochlear Diseases Ear Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Cranial Nerve Diseases Pathologic Processes |