Clinical trial NCT00109967 (phase 2, status: completed)
Conditions: recurrent mantle cell lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: temsirolimus
SMILES: CN1N=NC2=C(N=CN2C1=O)C(N)=O
Eligibility criteria:

        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