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