CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukemia

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)