Trial Condition(s):

Lymphoma, Non-Hodgkin

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

Bayer Identifier:

100389

ClinicalTrials.gov Identifier:

NCT00044551

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
29
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Cytotoxic Taxane (BAY59-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Centre Hospitalier Universitaire Brabois - Vandoeuvre-les-Na

VANDOEUVRE-LES-NANCY, France, 54500

Status
Completed
 
Locations

Centre Hospitalier Lyon Sud - Pierre Bénite

PIERRE BENITE, France, 69495

Status
Completed
 
Locations

LSU Health Sciences Center

Shreveport, United States, 71130-4228

Status
Terminated
 
Locations

Rotterdam Cancer Institute

Groene Hilledijk, Netherlands

Status
Completed
 
Locations

Kliniken und Polikliniken der Albert-Ludwigs-Universität

Freiburg, Germany, 79106

Status
Completed
 
Locations

Kent Oncology Centre

Maidstone, United Kingdom, ME16 9QQ

Status
Completed
 
Locations

North Shore University Hospital

Manhasset, United States, 11030-3876

Status
Terminated
 
Locations

New York Medical College

Valhalla, United States, 10595

Status
Terminated
 
Locations

Mt. Sinai Comprehensive Cancer Center

Miami Beach, United States, 33140

Status
Completed
 
Locations

Medical College of Wisconsin

Milwaukee, United States, 53226

Status
Completed
 
Locations

West Clinic

Memphis, United States, 38120

Status
Completed
 
Locations

Cleveland Clinic

Cleveland, United States, 44195

Status
Terminated
 
Locations

University of Washington Medical Center

Seattle, United States, 98195

Status
Terminated
 
Locations

University of Chicago

Chicago, United States, 60637

Status
Completed
 
Locations

Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

Status
Completed
 
Locations

Vrije Universiteit Medisch Centrum

AMSTERDAM, Netherlands, 1081 HV

Status
Completed
 
Locations

Montefiore Medical Center

Bronx, United States, 10467-2490

Status
Terminated
 
Locations

Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ

Status
Completed
 
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Completed
 
Locations

Hôtel Dieu - Paris

PARIS, France, 75151

Status
Completed
 
Locations

HemOnCare, PC

Brooklyn, United States, 11235-3518

Status
Completed
 
Locations

The Cancer Institute of New Jersey

New Brunswick, United States, 08903-2681

Status
Terminated
 
Locations

Upstate Medical University

Syracuse, United States, 13210-2399

Status
Completed
 

For details, please refer to trial results

Additional Information