Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle cell non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
OBJECTIVES: I. Determine the objective responses in patients with previously treated mantle cell non-Hodgkin's lymphoma treated with CCI-779. II. Determine the toxic effects of this drug in these patients. III. Determine whether this drug inhibits cell proliferation pathways in these patients. OUTLINE: 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 with stable disease receive a maximum of 6 courses. Patients with partial response receive a maximum of 12 courses. Patients with complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Given IV
North Central Cancer Treatment Group
Rochester, Minnesota, United States
Proportion of patients who achieve a confirmed CR or PR during the first 24 weeks of treatment defined by the International Workshop criteria
The proportion will be evaluated separately for each dose group. The proportion of patients who achieve a confirmed CR or PR, or success, will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Time frame: Up to 24 weeks
Time to progression
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Time frame: Time from registration to the time of progression, assessed up to 5 years
Overall survival
The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Time frame: Time from registration to death due to any cause, assessed up to 5 years
Progression-free survival
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
Time frame: Time from registration to progression or death due to any cause, assessed up to 5 years
Duration of response
Time frame: From the date of study registration until the date of progression in the subset of patients who respond, assessed up to 5 years
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