CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Condition: Recurrent Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: rituximab; temsirolimus
Intervention description: 375 mg/m^2 Given IV; 25 mg given IV
Intervention MeSH terms: Sirolimus; Rituximab; Temsirolimus; MTOR Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving CCI-779 together with rituximab works in
      treating patients with relapsed or refractory mantle cell lymphoma. Drugs used in
      chemotherapy, such as CCI-779, work in different ways to stop the growth of cancer cells,
      either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as
      rituximab, can block cancer growth in different ways. Some block the ability of cancer cells
      to grow and spread. Others find cancer cells and help kill them or carry cancer-killing
      substances to them. Giving CCI-779 together with rituximab may kill more cancer cells
    

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