Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma
- Conditions
- LeukemiaLymphoma
- Registration Number
- NCT00026429
- Lead Sponsor
- Pharmatech Oncology
- Brief Summary
RATIONALE: Biological therapies such as denileukin diftitox may be able to deliver cancer-killing substances directly to non-Hodgkin's lymphoma cells.
PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating patients who have non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES: I. Determine the efficacy of denileukin diftitox in patients with stages I-IV low- or intermediate-grade B-cell non-Hodgkin's lymphoma. II. Determine the safety of this drug in these patients.
OUTLINE: This is a multicenter study. Patients receive denileukin diftitox IV over 30-60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may receive up to 2 additional courses after achieving complete response. Patients are followed every 3 months until they have progressed or for 2 years from date of termination.
PROJECTED ACCRUAL: A total of 58 patients (29 with low-grade non-Hodgkin's lymphoma (NHL) and 29 with intermediate-grade NHL) will be accrued for this study within 12 months. The study may be stopped after accrual of 20 patients (10 with low-grade NHL and 10 with intermediate-grade NHL) if observed response rate is less than 1 in 10 for each stratum.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
🇺🇸Memphis, Tennessee, United States
Missouri Cancer Care, P.C.
🇺🇸St. Charles, Missouri, United States
Cancer and Blood Institute of the Desert
🇺🇸Rancho Mirage, California, United States
ION/Pharmatech Network
🇺🇸Pomona, California, United States
Coastal Cancer Center
🇺🇸Myrtle Beach, South Carolina, United States
Nassau Hematology/Oncology PC
🇺🇸Lake Success, New York, United States