- 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
- 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
- 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
- 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,
- 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,
- Patients should avoid CYP3A4 inhibiting foods including grapefruit and Seville orange
- 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