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Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma

A Single Arm, Monocenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Neurofibromatosis Type 2 - Related Vestibular Schwannoma

NCT01345136•Jonsson Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of the study is to determine if RAD001 treatment will shrink or slow the growth of the vestibular schwannoma(s) in Neurofibromatosis 2 (NF2) patients. Secondary objectives include determining if RAD001 treatment will improve hearing ability in NF2 patients. RAD001 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.

Detailed Description

This protocol is a Phase II, open-label, efficacy and safety study of single-agent RAD001 in patients with NF2. During the study, subjects will receive continuous daily oral treatment with RAD001 for up to 1 year or until tumor progression. Primary Objective: To determine whether RAD001 has an effect on the VS growth in patients with NF2 at a rate sufficient to submit the drug for further testing. Secondary Objectives: To determine whether RAD001 has an effect on the volume of other intracranial tumors, and to assess the effect of RAD001 on hearing function in patients with NF2 (when applicable).

Eligibility

Age

16 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of NF2 by National Institutes of Health (NIH) criteria
•Age ≥ 16 years
•Progressive VS growth during the previous 12 months.
•WHO performance status \> or = 2
•Adequate bone marrow, liver and renal function.
•For women of childbearing potential, no pregnancy or breast-feeding
•Willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
•Willingness to provide informed consent

Exclusion Criteria

•Inability to tolerate periodic MRI scans or gadolinium contrast.
•Inability to tolerate periodic audiologic testing or to understand a language with established scoring for word recognition testing.
•Inability to adequately perform volumetric measurement of at least 1 target lesionNote: Patients with cochlear or auditory brainstem implants may participate if a target lesion can be accurately assessed.
•Radiation therapy for the target lesion in the 60 months preceding inclusion in the study.
•Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug.
•Immunization with attenuated live vaccines within one week of study entry or during study period.
•Presence of a fungal infection requiring systemic antifungal treatment at enrollment
•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.
•Patients with a known hypersensitivity to everolimus or other types of rapamycin or to its excipients.
+1 more criteria

Locations (1)

University of California Los Angeles

Los Angeles, California, United States

Key Dates

Start Date

July 1, 2015

Primary Completion Date

February 6, 2024

Completion Date

February 6, 2024

Last Updated

February 13, 2024

Enrollment

ACTUAL participants

Conditions

Neurofibromatosis Type 2Neuroma, Acoustic

Interventions

RAD001, everolimus

DRUG

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Advanced Malignant NeoplasmCastleman Disease+37 more

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COMPLETED

Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy

NCT01129687

Neuroma, Acoustic

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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: February 13, 2024Data 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 RAD001 for Treatment of NF2-related Vestibular Schwannoma

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

Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy

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

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