Clinical trial NCT00436618 (phase 2, status: completed)
Conditions: leukemia, lymphoma, lymphoproliferative disorder
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, D47.Z1
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:

          -  Biopsy-proven* relapsed or refractory lymphoma, including the following:

               -  Aggressive lymphoma (closed to accrual as of 2/7/08 except for diffuse large B
                  cell lymphoma, grade III follicular lymphoma, or transformed lymphoma)

                    -  Transformed lymphoma

                    -  Diffuse large B-cell lymphoma

                    -  Mantle cell lymphoma

                    -  Grade 3 follicular lymphoma

                    -  Precursor B-cell lymphoblastic leukemia/lymphoma

                    -  Mediastinal (thymic) large B-cell lymphoma

                    -  Burkitt's lymphoma/leukemia

                    -  Precursor T-cell lymphoblastic leukemia/lymphoma

                    -  Primary cutaneous anaplastic large cell lymphoma

                    -  Primary systemic type anaplastic large cell lymphoma

               -  Indolent lymphoma (closed to accrual as of 8/18/08)

                    -  Small lymphocytic lymphoma/chronic lymphocytic leukemia

                    -  Grade 1 or 2 follicular lymphoma

                    -  Extranodal marginal zone B-cell lymphoma of MALT type

                    -  Nodal marginal zone B-cell lymphoma

                    -  Splenic marginal zone B-cell lymphoma

               -  Uncommon lymphoma (closed to accrual as of 9/2/08)

                    -  Unspecified peripheral T-cell lymphoma

                    -  Anaplastic large cell lymphoma (T and null cell type)

                    -  Lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia)

                    -  Central Nervous System (CNS) lymphoma

                    -  Post-transplant lymphoproliferative disorder

                    -  Mycosis fungoides/Sezary syndrome

                    -  Hodgkin's lymphoma

                    -  Primary effusion lymphoma

                    -  Blastic Natural Killer(NK)-cell lymphoma

                    -  Adult T-cell leukemia/lymphoma

                    -  Nasal type extranodal NK/T-cell lymphoma

                    -  Enteropathy type T-cell lymphoma

                    -  Hepatosplenic T-cell lymphoma

                    -  Subcutaneous panniculitis-like T-cell lymphoma

                    -  Angioimmunoblastic T-cell lymphoma

        NOTE: *Biopsies performed < 6 months prior to study entry are allowed; biopsy-proven CNS
        lymphoma (at any time) does not require a re-biopsy in order to be eligible for this study

          -  Previously treated disease

               -  Patients with aggressive lymphoma (closed to accrual as of 8/24/07) OR Hodgkin's
                  lymphoma must have received or be ineligible for potentially curative therapy,
                  including stem cell transplantation

          -  Measurable disease** by CT scan or MRI, defined by 1 of the following:

               -  At least 1 unidimensionally measurable lesion > 2 cm in diameter

                    -  Skin lesions may be used if they meet this criterion and are photographed
                       with a ruler

               -  More than 5,000/mm³ tumor cells in the blood

        NOTE: **For patients with lymphoplasmacytic lymphoma without measurable lymphadenopathy,
        measurable disease may be defined by bone marrow lymphoplasmacytosis with > 10%
        lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or
        lymphoplasmacytic cells on bone marrow biopsy AND quantitative Immunoglobulin M(IgM)
        monoclonal protein > 1,000 mg/dL

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group(ECOG) performance status 0-2

          -  Life expectancy > 3 months

          -  Absolute neutrophil count ≥ 1,000/mm³

          -  Platelet count ≥ 75,000/mm³

          -  Hemoglobin ≥ 8 g/dL

          -  Total bilirubin ≤ 2 times upper limit of normal (ULN) OR direct bilirubin ≤ 1.5 times
             ULN

          -  aspartate aminotransferase(AST) ≤ 3 times ULN (5 times ULN if liver involvement is
             present)

          -  Creatinine ≤ 2 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Willing to provide blood samples and portion of bone marrow aspirate and biopsy during
             study participation

          -  Able to swallow intact study medication tablets

          -  No other life-threatening illness (unrelated to tumor)

          -  No serious non-malignant disease (e.g., active infection or other condition) that, in
             the opinion of the investigator, would preclude study participation

          -  No other active malignancy requiring treatment or that would preclude study
             participation

          -  No known HIV positivity

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 3 weeks since prior myelosuppressive chemotherapy or biologic therapy (unless
             the patient has recovered from the nadir of the previous treatment)

          -  More than 3 weeks since prior radiotherapy (unless the acute side effects associated
             with therapy are resolved)

          -  Concurrent stable (i.e., not increased within the past month) chronic doses of
             corticosteroids, with a maximum dose of 20 mg of prednisone per day, is allowed if
             prescribed for disorders other than lymphoma (e.g., rheumatoid arthritis, polymyalgia
             rheumatica, adrenal insufficiency, or asthma)

               -  Non-escalating doses of steroids at the lowest possible dosing level are allowed
                  for CNS lymphoma

          -  No other concurrent investigational ancillary therapy

          -  No other concurrent chemotherapy, immunotherapy, or radiotherapy

          -  No concurrent participation in any other clinical trial involving a pharmacologic
             agent (e.g., drugs, biologics, immunotherapy, or gene therapy) for symptom control or
             therapeutic intent