Study of Axitinib in Patients With Neurofibromatosis Type 2 & Progressive

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if the study drug, AXITINIB, has any effect on tumors found in patients with Neurofibromatosis Type 2 (NF2).

Clinical Trial Description

NF2 is a condition that mainly affects the skin and nervous system. It causes non-cancerous tumors 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. AXITINIB is an oral drug (taken by mouth) that is approved by the United States Food and Drug Administration (FDA) for the treatment of other types of tumors. However, in this research study, AXITINIB is considered investigational because it is not approved by the FDA for treatment of NF2. Much is known regarding how well it is tolerated (handled), but investigators do not know if it is effective in treating NF2. This research study will test whether AXITINIB may shrink tumors commonly found in patients with NF2 or stop them from growing. This will help to decide if AXITINIB should be used to treat NF2 patients in the future. AXITINIB is a drug that has been used to treat various forms of cancer. It has not been studied for the treatment of tumors in NF2 patients. Investigators have selected AXITINIB for this clinical trial in patients with NF2 and NF2-related tumors because a very similar drug, bevacizumab, can shrink Vestibular Schwannomas (VS) in some NF2 patients. Pfizer, Inc., the manufacturer of the study drug, AXITINIB, will provide the AXITINIB being used in this study. Primary Objective: To estimate the objective volumetric response rates to axitinib in adult NF2 patients with VS. Secondary Objectives: To assess the toxicity of axitinib given daily in patients with NF2 and to examine the association of objective measures of response on MRI, i.e. volumetric tumor analysis with clinical measures of response, i.e. (audiogram), as well as quality of life assessments (NFTI-QOL). In addition, response in non-VS tumors, such as other schwannomas and meningiomas, may be explored. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02129647
Study type	Interventional
Source	NYU Langone Health
Contact
Status	Completed
Phase	Phase 2
Start date	April 2014
Completion date	February 5, 2019

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See also
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Completed	`NCT01880749` - Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas	Early Phase 1
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Completed	`NCT01125046` - Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas	Phase 2
Completed	`NCT03210285` - WES of NF2-associated in Comparison to Sporadic Vestibular Schwannomas - Correlation With Clinical Data
Completed	`NCT02934256` - Icotinib Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors	Phase 2
Terminated	`NCT01345136` - Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma	Phase 2
Completed	`NCT02104323` - Endostatin Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors	Phase 2
Completed	`NCT02246231` - Effect of Implant Position on Magnetic Resonance Image Distortion	N/A
Terminated	`NCT02282917` - Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma	Early Phase 1
No longer available	`NCT02589912` - Compassionate Use Arm - ABI541 ABI for 10 NF2 Patients

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms