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Spots Global Cancer Trial Database for BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma

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Trial Identification

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

Conditions

Lymphoma

Interventions

ortataxel

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Rasim Ahmet Gucalp, MD

Affiliation: Montefiore Medical Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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