CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
This phase II trial is studying how well CCI-779 works in treating patients with relapsed or
 refractory chronic lymphocytic leukemia. Drugs used in chemotherapy, such as CCI-779, work in
 different ways to stop cancer cells from dividing so they stop growing or die
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