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Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas

NCT01880749•NYU Langone Health

Summary

The primary objective is to estimate the proportions of vestibular schwannomas (VS) and meningiomas after 10 days of exposure to the study drug RAD001 at a dose of 10 mg daily, as determined by immunohistochemistry. This is a "phase 0" PK (pharmacokinetic) and PD (pharmacodynamic) study of RAD001 in patients with Neurofibromatosis Type 2-related and sporadic VS and meningiomas. Enrolled patients will take RAD001 prior to a scheduled VS or meningioma surgery, and blood and tissue samples will be obtained for further analysis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must satisfy all of the following eligibility criteria:
•Karnofsky performance status (KPS) ≥ 60%
•Absolute neutrophil count ≥ 1,000/mm³ (unsupported)
•Platelet count ≥ 100,000/mm³ (unsupported)
•Hemoglobin ≥ 8 g/dl (transfusion support allowed)
•Creatinine ≤ 1.5 times upper limit of normal (ULN\*) OR corrected glomerular filtration rate ≥ 70 ml/min
•Total bilirubin ≤ 1.5 times ULN\*
•ALT ≤ 2.5 times ULN\*
•Serum albumin ≥ 2 g/dl
•INR \< 1.3 (or \< 3 on anticoagulants)
+6 more criteria

Exclusion Criteria

•Patients with any of the following are ineligible for this research study:
•Patients with VS or meningiomas deemed very high surgical risk for stroke and/or other complications by the attending surgeon, such as meningiomas with major vascular or dural sinus infiltration.
•Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety.
•Symptomatic congestive heart failure or unstable angina pectoris.
•Uncontrolled diabetes, as defined by fasting serum glucose \>1.5 times ULN\*.
•Current active hepatic or biliary disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis (with exception of patients with Gilbert's syndrome and asymptomatic gallstones).
•History of hepatitis B or C. Note: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV serology, DNA and/or HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection. If no positive medical history for risk factors, serology is not required.
•Seropositivity or DNA/RNA positivity for hepatitis B or C, with the exception of patients who have received prior Hepatitis B vaccination and are Anti-HBs positive only.
•Known HIV seropositivity
•Neurologic deficits that are rapidly progressing: all neurologic signs and symptoms must have been stable for a week prior to first dose
+12 more criteria

Locations (1)

New York University School of Medicine

New York, New York, United States

Key Dates

Start Date

June 1, 2013

Primary Completion Date

December 1, 2019

Completion Date

December 1, 2019

Last Updated

May 13, 2020

Enrollment

ACTUAL participants

Conditions

Neurofibromatosis Type 2Vestibular SchwannomasMeningiomas

Interventions

RAD001

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: May 13, 2020Data 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.

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Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas

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

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

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

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