BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00039156
- Lead Sponsor
- Theradex
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have refractory non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
* Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with aggressive refractory non-Hodgkin's lymphoma treated with BAY 59-8862.
* Determine the overall survival in patients treated with this drug.
* Determine the time to progression in patients treated with this drug.
* Determine the duration of response (CR and PR) in patients treated with this drug.
* Determine the qualitative and quantitative toxicity profile of this drug in this patient population.
* Determine the pharmacokinetic profile of this drug in selected patients.
OUTLINE: This is a multicenter, open-label study.
Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months thereafter for up to 2 years.
PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
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 (15)
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
HemOnCare, P.C.
🇺🇸Brooklyn, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Albert Einstein Clinical Cancer Center
🇺🇸Bronx, New York, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
West Clinic
🇺🇸Memphis, Tennessee, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
St. Paul's Hospital - Vancouver
🇨🇦Vancouver, British Columbia, Canada
New York Medical College
🇺🇸Valhalla, New York, United States