This study is to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in patients with Mantle Cell Lymphoma who are refractory or intolerant to Velcade® therapy and who have received at least one prior antineoplastic agent other than Velcade®, either separately or in combination with Velcade® (see inclusion criteria). Intolerance to Velcade® therapy is determined by the study investigator based on clinical evaluations. Patients are considered refractory to Velcade® if they have documented radiological progression on or within 12 months of the last dose of Velcade® when given alone or, on or within 12 months of the last dose of the last component of a combination therapy which included Velcade®.
- Adult patients (> 18 years old) with Mantle Cell Lymphoma that has been confirmed by central pathology review (archival diagnostic tumor specimen required)
- Patients with mantle cell lymphoma who have documented refractory disease to bortezomib (Velcade®) or who have documented intolerance to Velcade® therapy. Intolerance to Velcade® is determined by the study investigator based on clinical evaluations. Patients are considered refractory to Velcade® if they have documented radiological progression on or within 12 months of last dose of Velcade® when given alone or, on or within 12 months from the last dose of the last component of a combination therapy which included Velcade®). Patients are considered refractory to Velcade®, if Velcade® is part of a combination treatment for the disease.
- Patients must have received at least one prior antineoplastic agent, other than Velcade® either separately or in combination with bortezomib (Velcade®).
- At least one site of measurable nodal disease at baseline >2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan (or MRI, only if CT scan can not be performed)
- ECOG performance status = 0, 1 or 2
- Life expectancy ≥ 3 months
- Adequate bone marrow, liver and renal function
- Platelets ≥ 75 x 109/L (untransfused platelets)
- Patients who are currently receiving anticancer therapies or have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation, antibodies, targeted therapy etc.) are not eligible
- Previous treatment with mTOR inhibitors (e.g. everolimus, sirolimus, temsirolimus, etc)
- Patients with prior allogeneic stem cell transplant
- Grade 3 or 4 unresolved toxicity from prior antineoplastic therapies
- Currently taking other investigational agents or received other investigational drugs within 4 weeks of the start of study drug
- Patients with CNS lymphoma are not eligible; head MRI (or CT if MRI is not available) is required prior to study entry
- Use of chronic, systemic corticosteroids or another immunosuppressive agent, except prednisone ≤ 20 mg daily (or equivalent) for adrenal insufficiency (must have been on a stable dosage regimen for ≥ 4 weeks prior to the first treatment with RAD001)
- HIV positive patients are not eligible; (HIV testing is not required for study entry; review of previous medical records is required)
- Uncontrolled hyperlipidemia (≥ Grade 3 hyperlipidemia despite optimal supportive medical therapy)
- Active, bleeding disorders or major surgery within 4 weeks of starting study drug
- Severe and/or uncontrolled medical conditions such as symptomatic congestive heart failure (NYHA Class III or IV), unstable angina, myocardial infarction within 6 months or study start, severely impaired lung function, cirrhosis, chronic active/persistent hepatitis.
- History of another primary malignancy ≤ 3 years prior to study entry
Last updated: 05/10/2013
NCT ID: NCT00702052