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