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Brief Title: BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
Official Title: An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma
Study ID: NCT00039156
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Albert Einstein Clinical Cancer Center, Bronx, New York, United States
HemOnCare, P.C., Brooklyn, New York, United States
North Shore University Hospital, Manhasset, New York, United States
State University of New York - Upstate Medical University, Syracuse, New York, United States
New York Medical College, Valhalla, New York, United States
West Clinic, Memphis, Tennessee, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
St. Paul's Hospital - Vancouver, Vancouver, British Columbia, Canada
Name: Rasim Ahmet Gucalp, MD
Affiliation: Montefiore Medical Center
Role: STUDY_CHAIR