Status:
COMPLETED
Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas
Lead Sponsor:
NYU Langone Health
Conditions:
Neurofibromatosis Type 2
Vestibular Schwannomas
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 immuno...
Eligibility Criteria
Inclusion
- 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)
- Patients taking a cholesterol-lowering agent must be on a single medication and on a stable dose for at least 4 weeks
- Fasting serum cholesterol ≤ 300 mg/dl OR ≤ 7.75 mmol/l AND fasting triglycerides ≤ 2.5 times ULN\*.
- Fully recovered from acute toxic effects of any prior chemotherapy, biological modifiers or radiotherapy
- Any neurologic deficits must be stable for ≥ 1 week
- Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. The anti-proliferative activity of this experimental drug may be harmful to the developing fetus.
- Able to provide written informed consent
Exclusion
- 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
- Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant.
- Anti-tumor therapy (i.e. chemotherapeutics or investigational agents or immunotherapy) within 4 weeks prior to enrollment
- Radiation therapy to a study target lesion within 6 months
- Prior therapy with mTOR inhibitors, including sirolimus, temsirolimus, deforolimus within 6 months prior to enrollment
- Known hypersensitivity to RAD001 or other rapamycins (sirolimus, temsirolimus, deforolimus)
- Patients with a concurrent malignancy
- Patients treatment with systemic steroids or another immunosuppressive agent. Patients with endocrine deficiencies are allowed to receive physiologic or stress doses of steroids if necessary.
- Patients cannot receive CYP3A4 inhibiting drugs including antibiotics (clarithromycin, erythromycin, troleandomycin), anti-HIV agents (delaviridine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, lopinavir), antifungals (itraconazole, ketoconazole, fluconazole at doses \> 200 mg/day, voriconazole), antidepressants (nefazodone, fluovoxamine), calcium channel blockers (verapamil, diltiazem) oramiodarone
- Patients should avoid CYP3A4 inhibiting foods including grapefruit and Seville orange juice.
- Patients cannot receive CYP3A4 inducing anticonvulsants including carbamazepine, felbamate, phenobarbital, phenytoin, primidone and oxcarbazepine, or other CYP3A4 inducers such as St. John's Wort
- Patients who previously received CYP3A4 inducers or inhibitors must have discontinued these medications within at least 1 week prior to study entry and can re-start them 1 week post-operatively (or earlier if determined to be of clinical benefit, as determined by the treating physician).
- of institutional norms
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01880749
Start Date
June 1 2013
End Date
December 1 2019
Last Update
May 13 2020
Active Locations (1)
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1
New York University School of Medicine
New York, New York, United States, 10016