A Phase II Study of CCI-779 in Patients With Relapsed, Refractory or Transformed Chronic Lymphocytic Leukemia

Study start date: May 1, 2004

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