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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
University of Chicago
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Evanston Hospital CCOP
Evanston, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Adventist La Grange Memorial Hospital
La Grange, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
...and 3 more locations
Objective Overall Response Rate
The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires \>=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.
Time frame: Up to 6 years
Duration of Response
Duration of response was the time from date of response to date of progression and evaluated among participants with response. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as \>=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.
Time frame: Up to 6 years
Overall Survival
The overall survival was evaluated using the Kaplan-Meier estimator.
Time frame: Up to 6 years
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