CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma
Recurrent Mantle Cell Lymphoma
About this trial
This is an interventional treatment trial for Recurrent Mantle Cell Lymphoma
Eligibility Criteria
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
Sites / Locations
- North Central Cancer Treatment Group
Arms of the Study
Arm 1
Experimental
Treatment
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with stable disease receive a maximum of 6 courses. Patients with partial response receive a maximum of 12 courses. Patients with CR receive 2 additional courses beyond CR.