CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma

Inclusion Criteria:

• Histologically confirmed mantle cell non-Hodgkin's lymphoma (MCL)
• Relapsed, refractory, or stable disease after prior chemotherapy, radiotherapy, or immunotherapy

• Unidimensionally measurable lymph node or lesion

  • At least 2.0 cm by CT scan or MRI OR at least 1.5 cm by physical exam

  • One of the following measurement parameters may be used:

    • Splenic enlargement may be used as a measurement parameter if spleen is palpable at least 3.0 cm across left costal margin
    • Malignant lymphocytosis may be used as a measurement parameter if absolute lymphocyte count is at least 5,000/mm^3
• No known CNS involvement (parenchymal mass or leptomeningeal involvement)
• Performance status - ECOG 0-2
• At least 3 months
• See Disease Characteristics
• Absolute neutrophil count ≥ 1,000/mm^3
• Platelet count ≥ 75,000/mm^3
• Hemoglobin ≥ 8 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Direct bilirubin ≤ 1.5 times ULN
• AST ≤ 3 times ULN (5 times ULN if liver metastases are present)
• Creatinine ≤ 2 times ULN
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Cholesterol ≤ 350 mg/dL
• Triglycerides ≤ 400 mg/dL
• HIV negative
• No other active malignancy requiring treatment or that would preclude study participation
• No other concurrent uncontrolled illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation
• See Disease Characteristics
• Prior high-dose therapy with stem cell transplantation allowed
• At least 7 days since prior immunotherapy or other non-myelosuppressive biologic response modifiers
• See Disease Characteristics
• See Biologic therapy
• At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No other concurrent chemotherapy for MCL
• Concurrent corticosteroids for adrenal insufficiency allowed
• See Disease Characteristics
• At least 3 weeks since prior radiotherapy
• No concurrent radiotherapy for MCL
• Any number of prior treatments allowed
• No other concurrent investigational or commercial agents for MCL
• No concurrent drugs that induce cytochrome p450 (e.g., carbamazepine, phenobarbital, phenytoin, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide)
• No concurrent immunosuppressive therapies