OBJECTIVES: I. Determine the activity of CCI-779 in patients with relapsed, refractory, or transformed chronic lymphocytic leukemia. OUTLINE: Patients are stratified according to disease (relapsed or refractory chronic lymphocytic leukemia \[CLL\] vs transformed CLL). Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response may receive 3 consolidation courses of therapy.
Inclusion Criteria: * Diagnosis of chronic lymphocytic leukemia (CLL) * Relapsed, refractory, or transformed disease * Relapsed disease defined as symptomatic loss of a prior partial or complete response to a regimen containing a purine analog and/or a monoclonal antibody AND evidence of disease progression * Primary resistant disease defined as failure to achieve an objective response to a regimen containing a purine analog and/or a monoclonal antibody * Transformed CLL (Richters transformation), must meet both of the following criteria: * Histologically confirmed lymphoma * Measurable disease * No CNS disease * Performance status - ECOG 0-2 * Bilirubin ≤ 2 mg/dL (unless elevated due to Gilbert's disease) * SGOT and SGPT \< 3 times upper limit of normal * Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement) * 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 * HIV-positive patients allowed provide CD4 counts are normal and no AIDS-defining disease is present * No history of 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 concurrent uncontrolled illness * See Disease Characteristics * No concurrent prophylactic hematopoietic colony-stimulating factors * See Disease Characteristics * More than 2 weeks since prior cytotoxic chemotherapy and recovered * More than 2 weeks since prior radiotherapy and recovered * No other concurrent investigational or antitumor agents * No other concurrent cytotoxic agents * No concurrent combination antiretroviral therapy for HIV-positive patients
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