A Phase II Study of CCI-779 in B-cell Lymphoma and CLL
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
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
Objective overall response rate
Up to 6 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Iowa||Iowa City, Iowa 52242|
|Loyola University Medical Center||Maywood, Illinois 60153|
|Ingalls Memorial Hospital||Harvey, Illinois 60426|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|La Grange Memorial Hospital||La Grange, Illinois 60525|
|Decatur Memorial Hospital||Decatur, Illinois 62526|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|M D Anderson Cancer Center||Houston, Texas 77030|
|Northern Indiana Cancer Research Consortium||South Bend, Indiana|
|Froedtert and the Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Fort Wayne Medical Oncology and Hematology Inc - State Boulevard||Fort Wayne, Indiana 46845|
|Oncology Care Associates PLLC||St. Joseph, Michigan 49085|
|Evanston Hospital CCOP||Evanston, Illinois 60201|