Loading clinical trials...

Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT02129647•NYU Langone Health

View on ClinicalTrials.gov

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).

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years
•Meets clinical diagnostic criteria for NF2
•At least one volumetrically measurable and ≥1 cc NF2-related VS (histological confirmation not required)
•MRI evidence of progression (either as \>2 mm increase in maximum linear diameter on conventional MRI, or a \>20%volume increase by 3D volumetrics) over the past ≤18 months, OR progressive hearing loss, defined as a decline in word recognition score below the 95% critical difference interval from baseline score related to VS (i.e., not due to prior interventions such as surgery or radiation)
•Karnofsky performance status (PS) 60-100%. Note: Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
•Adequate bone marrow function as shown by: absolute neutrophil count ≥1.5 x 10\^9/L, Platelets ≥100 x 10\^9/L, Hb \>9 g/dL
•Adequate liver function as shown by:
•serum bilirubin ≤1.5 x upper limit of normal (ULN)
•ALT and AST ≤2.5x ULN
•INR ≤1.5. (anticoagulation with low molecular weight heparin is allowed if on a stable dose for \>2 weeks at time of enrollment.)
+3 more criteria

Exclusion Criteria

•Patients currently receiving medical anticancer therapies or who have received medical anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, antibody based therapy, etc.)
•Radiation therapy to a study target tumor within 1 year prior to enrollment, or any radiation therapy within 4 weeks prior to enrollment.
•Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
•Prior treatment with bevacizumab or other agents targeting vascular endothelial growth factor (VEGF) or VEGF receptor
•Prior treatment with any investigational drug within the preceding 4 weeks
•Unstable or rapidly progressive disease, including patients who require glucocorticoids for symptomatic control of brain or spinal tumors
•Treatment with strong CYP3A4 enzyme inhibitors or inducers, including but not limited to ketoconazole, itraconazole, ritonavir, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital and St. John's wort
•Requirement of therapeutic anticoagulant therapy with oral vitamin K antagonists; low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed; therapeutic use of low molecular weight heparin (or similar parenteral drug) for venous-thromboembolic disease is allowed.
•Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
•Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
+11 more criteria

Locations (1)

NYU Langone Medical Center

New York, New York, United States

Key Dates

Start Date

April 1, 2014

Primary Completion Date

February 5, 2019

Completion Date

February 5, 2019

Last Updated

December 1, 2021

Enrollment

ACTUAL participants

Conditions

Neurofibromatosis Type 2Vestibular Schwannomas

Interventions

Axitinib

DRUG

Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease

NCT01552434

Advanced Malignant NeoplasmCastleman Disease+37 more

View study

TERMINATEDPHASE2

Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma

NCT01345136

Neurofibromatosis Type 2Neuroma, Acoustic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease

Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma

Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas

Bevacizumab for Symptomatic Vestibular Schwannoma in Neurofibromatosis Type 2 (NF2)

WES of NF2-associated in Comparison to Sporadic Vestibular Schwannomas - Correlation With Clinical Data