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