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Evaluation of Bay 59-8862 in Patients with Aggressive, Refractory Non-Hodgkin's Lymphoma



Evaluation of Bay 59-8862 in Patients with Aggressive, Refractory Non-Hodgkin's Lymphoma

For Condition: Lymphoma, Non-Hodgkin
Status: Terminated
Sponsor(s): Bayer Corporation ,
Synopsis: Almost two-thirds of lymphoma cases are Non-Hodgkin’s Lymphomas (NHL). NHL is a malignant process that affects lymphoid cells found both in the lymph nodes and extranodally. Incidence and mortality rates from NHL are highest in developed countries. While many patients with aggressive NHL are curable with initial anthracycline-containing regimens, the majority of patients will relapse or prove refractory to initial therapy. The prognosis of patients with disease recurrence following a multidrug regimen is also limited. The current protocol is designed to test the safety and efficacy of BAY 59-8862 in patients with Aggressive Refractory Non-Hodgkin’s Lymphoma.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - measurable disease as defined by the presence of at least one measurable lesion - failed at least one prior therapy or has achieved remission but has progressed or relapsed within 6 months of therapy - life expectancy of at least 12 weeks - adequate bone marrow, liver and kidney function Exclusion Criteria: - excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers - excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant - others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation
Total Enrollment: 140

Location and Contact Information:

University of Chicago
Chicago,  Illinois,  60637-1470
United States
 

North Shore University Hospital
Manhasset,  New York,  11030-3876
United States
 

HemOnCare, PC
Brooklyn,  New York,  11235-3518
United States
 

Mt. Sinai Comp. Cancer Center
Miami,  Florida,  33140
United States
 

LSU Health Sciences Center
Shreveport,  Louisiana,  71130-4299
United States
 

The Cancer Institute of New Jersey
New Brunswick,  New Jersey,  08901
United States
 

West Clinic
Memphis,  Tennessee,  38120
United States
 

New York Medical College
Valhalla,  New York,  10595
United States
 

Medical College of Wisconsin
Milwaukee,  Wisconsin,  53226-3596
United States
 

University of Washington Medical Center
Seattle,  Washington,  98195
United States
 

The Cleveland Clin. Foundation
Cleveland,  Ohio,  44195
United States
 

SUNY Upstate Medical University
Syracuse,  New York,  13210
United States
 

Montefiore Medical Center
Bronx,  New York,  10467-2490
United States
 


Additional Information:
Study ID Numbers:
  Protocol No. 100389; 
Study Start Date: March 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044551

Other Lymphoma, Non-Hodgkin Studies:
1. Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors

2. Meaning-Centered Psychotherapy in Advanced Cancer

3. A Study of Azidothymidine (AZT) in the Treatment of HIV Infection in Patients Receiving a Bone Marrow Transplant

4. Pegfilgrastim PBPC Mobilization Study

5. Proleukin in combination with Rituxan in patients with intermediate and high-grade Non-Hodgkin's lymphoma.

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Evaluation of Bay 59-8862 in Patients with Aggressive, Refractory Non-Hodgkin's Lymphoma

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