Clinical trial NCT00516412 (phase 2, status: completed)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: everolimus
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        DISEASE CHARACTERISTICS:

        Inclusion criteria:

          -  Histologically or cytologically confirmed relapsed or
             chemotherapy/immunotherapy-resistant mantle cell lymphoma

               -  No more than 3 lines of prior systemic treatment

          -  At least one measurable lesion ≥ 15 mm in its greatest transverse diameter by CT scan

        Exclusion criteria:

          -  Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningosis)

          -  Newly diagnosed mantle cell lymphoma

          -  Patients suitable for intensive treatment (e.g., hyperfractionated cyclophosphamide,
             vincristine, doxorubicin hydrochloride and dexamethasone with high-dose methotrexate
             and cytarabine [HyperCVAD])

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  WHO performance status ≤ 2

          -  Creatinine clearance ≥ 30mL/min

          -  Bilirubin ≤ 2 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2 times ULN

          -  AST and ALT ≤ 2 times ULN

          -  Neutrophils ≥ 1,500/mm³ (≥ 1,000/mm³ with marrow infiltration)

          -  Thrombocytes ≥ 100,000/mm³ (≥ 75,000/mm³ in case of bone marrow infiltration)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 12 months after study
             participation

        Exclusion criteria:

          -  Prior or concurrent hematological malignancies

               -  Patients with prior solid organ tumors that required no treatment over the last 5
                  years and are currently free of disease are eligible

          -  Cardiovascular disease including any of the following:

               -  NYHA class III or IV congestive heart failure

               -  Unstable angina pectoris

               -  Significant arrhythmia or arrhythmia requiring chronic treatment

               -  Myocardial infarction in the last 3 months

          -  Serious underlying medical condition which could impair the ability of the patient to
             participate in the trial including any of the following:

               -  Uncontrolled diabetes mellitus

               -  Gastric ulcers

               -  Active autoimmune disease

               -  Ongoing infection (e.g., HIV or hepatitis)

        PRIOR CONCURRENT THERAPY:

        Exclusion criteria:

          -  Prior radiation where the indicator lesion(s) are in the irradiated field

          -  Prior organ transplantation

          -  Participation in another clinical trial within 30 days prior to study entry

          -  Concurrent anticancer drugs/treatments or experimental medications

          -  Other concurrent investigational therapy

          -  Other concurrent chemotherapy, immunotherapy, or radiotherapy (including palliative
             radiotherapy)