A Phase II Study of CCI-779 in B-cell Lymphoma and CLL
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective overall response rate
Up to 6 years
No
Sonali Smith
Principal Investigator
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
NCI-2009-00047
NCT00290472
March 2004
Name | Location |
---|---|
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 |