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