CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Inclusion Criteria

• Histologically confirmed* mantle cell lymphoma (MCL)
• Relapsed, refractory, or stable disease after prior treatment
• Tumor must be cyclin D-1 by immunohistochemistry OR 11;14 translocation by fluorescent in situ hybridization or cytogenetics
• Measurable disease, defined as ≥ 1 of the following:
• Unidimensionally measurable lymph node or tumor mass ≥ 2 cm by CT scan or MRI
• Splenic enlargement if spleen is palpable ≥ 3 cm below the left costal margin
• Malignant lymphocytosis if absolute lymphocytic count ≥ 5,000 AND lymphocytes confirmed to be monoclonal by flow cytometry
• No known central nervous system involvement (e.g., parenchymal mass or leptomeningeal involvement)
• Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
• At least 3 months
• No other concurrent treatment for MCL
• Absolute neutrophil count ≥ 1,000/mm^3
• Platelet count ≥ 75,000/mm^3
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Direct bilirubin < 1.5 times ULN
• Aspartate aminotransferase (AST) ≤ 3 times ULN (5 times ULN if liver involvement by MCL is present)
• Creatinine ≤ 2 times ULN
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• Cholesterol ≤ 350 mg/dL
• Fasting triglycerides < 400 mg/dL
• No known HIV positivity
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No other uncontrolled illness
• No other active malignancy requiring treatment OR that would preclude assessment of response to study drugs
• Prior biologic response modifiers allowed
• Prior immunotherapy allowed
• Prior high-dose therapy with stem cell support (i.e., stem cell transplantation) allowed
• No concurrent prophylactic growth factor to support neutrophils
• Prior chemotherapy allowed
• No other concurrent chemotherapy
• No concurrent corticosteroids to induce an antitumor response
• Concurrent corticosteroids (≤ 10 mg/day of prednisone or equivalent) for adrenal insufficiency or acute allergic reactions allowed
• Prior radiotherapy allowed
• No prior treatment with a mammalian target of rapamycin (mTOR) inhibitor
• No other concurrent investigational or commercial agents or therapies for MCL
• No other concurrent immunosuppressive therapy