BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
Recruitment status was: Active, not recruiting
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma|
|Study Start Date:||January 2002|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039156
|United States, Florida|
|Mount Sinai Comprehensive Cancer Center|
|Miami Beach, Florida, United States, 33140|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Louisiana|
|Veterans Affairs Medical Center - Shreveport|
|Shreveport, Louisiana, United States, 71101|
|Louisiana State University Health Sciences Center - Shreveport|
|Shreveport, Louisiana, United States, 71130-3932|
|United States, New Jersey|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, New York|
|Albert Einstein Clinical Cancer Center|
|Bronx, New York, United States, 10461|
|Brooklyn, New York, United States, 11235|
|North Shore University Hospital|
|Manhasset, New York, United States, 11030|
|State University of New York - Upstate Medical University|
|Syracuse, New York, United States, 13210|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|United States, Tennessee|
|Memphis, Tennessee, United States, 38120|
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226-3596|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|St. Paul's Hospital - Vancouver|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Study Chair:||Rasim Ahmet Gucalp, MD||Montefiore Medical Center|