CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

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