Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

Inclusion Criteria:

• Histologically confirmed relapsed or refractory lymphoma

  • Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) (phase I)

  • Mature NHL, including the following cell types (phase II):

    • Diffuse large B-cell lymphoma (DLBCL) with germinal center versus non-germinal center phenotype as established by IHC
    • Follicular lymphoma
    • Lymphoma not otherwise specified (e.g., HL, T-NHL, marginal zone lymphoma, lymphoplasmacytic lymphoma)
  • No chronic lymphocytic leukemia or small lymphocytic lymphoma

• No bone marrow biopsies (with the exception of lymphoplasmacytic lymphoma) as sole means of diagnosis

  • Fine needle biopsies not allowed
• Must have received prior therapy

• Measurable disease, defined as any tumor mass > 1 cm

  • Non-measurable disease alone, including the following, is not allowed:

    • Bone lesions
    • Ascites
    • Pleural/pericardial effusion
    • Lymphangitis cutis/pulmonis
    • Bone marrow

    • Waldenstrom's macroglobulinemia

      • For Waldenstrom's macroglobulinemia measurable disease is defined as ≥ 1 lesion with a single diameter of > 2 cm by CT or bone marrow involvement > 10% malignant cells and quantitative monoclonal protein (IgM, IgG, IgA) > 1,000 mg/dL
• No known CNS involvement
• No patients with relapsed or refractory DLBCL or HL who are eligible and willing to undergo potentially curative stem cell transplantation
• ECOG performance status 0-2
• ANC ≥ 1,000/μL
• Platelet count ≥ 75,000/μL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Gilbert syndrome)
• AST/ALT ≤ 2.5 times ULN
• Creatinine clearance ≥ 60 mL/min
• Fasting serum cholesterol ≤ 350 mg/dL
• Fasting serum triglycerides ≤ 2.5 times ULN
• Not pregnant or nursing
• Two negative pregnancy tests (i.e., first test within 10-14 days before lenalidomide and second test within 24 hours of starting lenalidomide)
• Fertile patients must agree to continue abstinence or begin using 2 methods of effective contraception (one highly effective and one additional effective method) at the same time for ≥ 28 days prior to start lenalidomide

• HIV-positive patients allowed provided the following criteria are met:

  • No AIDS-defining illness
  • CD4 count ≥ 400 cells/mm^3
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to temsirolimus or lenalidomide

• No currently active second malignancy other than nonmelanoma skin cancers

  • Patients who have completed anticancer therapy for second malignancy and are considered by their physicians to have < 30% risk of relapse allowed

• No deep venous thrombosis/pulmonary embolism (DVT/PE) within the past 3 months

  • Patients with DVT/PE > 3 months ago must receive prophylactic aspirin or low-molecular weight heparin

• No uncontrolled intercurrent illness including, but not limited to, any of the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness and/or social situations that would limit compliance with study requirements
• No other concurrent anticancer commercial agents or therapies
• Any number of prior therapies allowed, including prior autologous transplantation
• More than 4 weeks since prior and no other concurrent chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
• More than 7 days since prior and no concurrent antiretroviral therapy (including HAART)

• No corticosteroids within the past 14 days except for maintenance of non-malignant disease

  • Prednisone or equivalent maintenance therapy dose < 10 mg/day
  • No concurrent dexamethasone or other steroidal antiemetics
• No concurrent pegfilgrastim
• No other concurrent investigational agents