Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of ONTAK® (Denileukin Diftitox, DABIL-2) in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia|
|Study Start Date:||August 2002|
|Study Completion Date:||June 2005|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
- Determine the complete and partial response rate in patients with fludarabine-refractory B-cell chronic lymphocytic leukemia treated with denileukin diftitox.
- 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.
|United States, California|
|St. Joseph Hospital Regional Cancer Center - Orange|
|Orange, California, United States, 92868-3849|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611|
|United States, Indiana|
|Medical Center Vincennes|
|Vincennes, Indiana, United States, 47591|
|United States, Louisiana|
|Cancer Care Specialists|
|Houma, Louisiana, United States, 70360|
|Feist-Weiller Cancer Center at Louisiana State University Health Sciences|
|Shreveport, Louisiana, United States, 71130-3932|
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Southeastern Medical Oncology Center|
|Goldsboro, North Carolina, United States, 27534|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1082|
|United States, South Carolina|
|Gibbs Regional Cancer Center at Spartanburg Regional Medical Center|
|Spartanburg, South Carolina, United States, 29303|
|United States, Tennessee|
|Chattanooga Oncology and Hematology Associates|
|Chattanooga, Tennessee, United States, 37404|
|United States, Texas|
|Southwest Regional Cancer Center - Central|
|Austin, Texas, United States, 78705|
|Study Chair:||Arthur E. Frankel, MD||Comprehensive Cancer Center of Wake Forest University|