Malignant Neoplasm Clinical Trial
Official title:
A Phase II Study of CCI-779 in B-cell Lymphoma and CLL
Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
PRIMARY OBJECTIVES:
I. Determine the complete and partial response rate in patients with recurrent or refractory
B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with CCI-779.
II. Determine the toxicity and safety of this drug in these patients. III. Correlate the
degree of activation of P13/AKT/mTOR pathway and levels of CDK inhibitors with response in
patients treated with this drug.
IV. Correlate CCI-779 induced inactivation of mTOR with response in these patients.
OUTLINE: Patients are stratified according to disease (aggressive lymphoma [group A] vs
follicular lymphoma [group B] vs small lymphocytic lymphoma or chronic lymphocytic leukemia
[group C]).
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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