Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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