RATIONALE: Biological therapies, such as denileukin diftitox, may interfere with the growth of cancer cells and slow the growth of chronic lymphocytic leukemia. PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with fludarabine-refractory B-cell chronic lymphocytic leukemia.
OBJECTIVES: Primary * Determine the complete and partial response rate in patients with fludarabine-refractory B-cell chronic lymphocytic leukemia treated with denileukin diftitox. Secondary * Determine the toxicity profile of this drug in these patients. * Determine the response rate in patients (regardless of CD25 receptor density) treated with this drug. * Determine the progression-free survival and overall survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive denileukin diftitox IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response after 8 courses proceed to follow-up. Patients achieving a partial response or stable disease after 8 courses may continue treatment at the discretion of the investigator. Patients are followed every 3 months for 1 year and then annually until relapse. PROJECTED ACCRUAL: A total of 12-44 patients will be accrued for this study within 1 year.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Medical Center Vincennes
Vincennes, Indiana, United States
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Cancer Care Specialists
Houma, Louisiana, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Chattanooga Oncology and Hematology Associates
Chattanooga, Tennessee, United States
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