Spots Global Cancer Trial Database for Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
Official Title: A Phase II Study of ONTAK® (Denileukin Diftitox, DABIL-2) in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
Study ID: NCT00082940
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
Southwest Regional Cancer Center - Central, Austin, Texas, United States
Contact Details
Name: Arthur E. Frankel, MD
Affiliation: Wake Forest University Health Sciences
Role: STUDY_CHAIR
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