CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Condition: B-cell Chronic Lymphocytic Leukemia; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Malignant Neoplasm; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Splenic Marginal Zone Lymphoma; Waldenström Macroglobulinemia
MeSH terms: Burkitt Lymphoma; Lymphoma; Leukemia; Lymphoma, Follicular; Lymphoma, B-Cell; Leukemia, Lymphoid; Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell, Marginal Zone; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Waldenstrom Macroglobulinemia; Recurrence
Intervention: temsirolimus
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from
      dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works
      in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic
      lymphocytic leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed B-cell non-Hodgkin's lymphoma, including the
             following subtypes:

               -  Aggressive B-cell lymphoma (Group A)

                    -  Diffuse large B-cell lymphoma

                    -  Transformed lymphoma

               -  Follicular lymphoma (Group B)

               -  Small lymphocytic lymphoma

                    -  Chronic lymphocytic leukemia (CLL) (Group C)

                    -  Other B-cell small lymphocytic disorders

          -  No mantle cell lymphoma

          -  No potentially curative treatment options because of lack of response, relapse, or
             ineligibility

          -  Relapsed or refractory disease

          -  Patients with refractory disease (i.e., less than a partial response to the last
             treatment) must have received no more than 3 prior regimens (group A)

          -  Patients with sensitive disease (i.e., at least a partial response to the last
             treatment) must have received no more than 4 prior regimens (group A)

          -  Patients who have failed prior autologous transplantation are eligible (group A)

               -  No more than 5 prior regimens (groups B and C)

               -  The salvage regimen, conditioning regimen, and any maintenance therapy are
                  considered 1 regimen

          -  Prior rituximab or alemtuzumab is not considered prior therapy

          -  No limitation to the amount of prior radiotherapy

          -  No CNS involvement

          -  Performance status: ECOG 0-2 OR Karnofsky 60-100%

          -  Life expectancy more than 3 months

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  No prior allergic reactions attributed to compounds of similar chemical or biological
             composition to CCI-779

          -  No ongoing or active infection

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the
             cervix Completed therapy and considered < 30% risk of relapse

          -  No other concurrent uncontrolled illness

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No concurrent prophylactic hematopoietic colony-stimulating factors

          -  No concurrent pegfilgrastim

          -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
             recovered

          -  More than 4 weeks since prior radiotherapy and recovered

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No concurrent unconventional therapies, food, or vitamin supplements containing
             Hypericum perforatum (St. John's wort)

          -  No other concurrent known inducers of CYP3A4

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy

          -  Measurable disease*

               -  At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques
                  OR >= 10 mm by spiral CT scan [Note: *Only bone marrow or peripheral blood
                  involvement required for CLL and Waldenstrom's macroglobulinemia ]

          -  Absolute neutrophil count >= 1,000/mm3

          -  Bilirubin =< 1.5 times upper limit of normal (ULN)

          -  AST and ALT =< 2.5 times ULN

          -  Creatinine =< 1.5 times ULN

          -  Fasting cholesterol =< 350 mg/dL

          -  Fasting triglycerides =< 400 mg/dL

          -  Platelet count >= 50, 000/mm3 (> 20,000/mm3 for patients with thrombocytopenia due to
             bone marrow involvement)