Study Completed

Lymphoma, Non-Hodgkin

Bayer Identifier:

100389

ClinicalTrials.gov Identifier:

NCT00044551

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Both

Age

18 Years

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

Trial Dates

February 2002 - July 2003

Phase

Phase 2

Could I Receive a placebo

Products

Cytotoxic Taxane (BAY59-8862)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Centre Hospitalier Universitaire Brabois - Vandoeuvre-les-Na	VANDOEUVRE-LES-NANCY, 54500, France
Completed	Centre Hospitalier Lyon Sud - Pierre Bénite	PIERRE BENITE, 69495, France
Terminated	LSU Health Sciences Center	Shreveport, 71130-4228, United States
Completed	Rotterdam Cancer Institute	Groene Hilledijk, Netherlands
Completed	Kliniken und Polikliniken der Albert-Ludwigs-Universität	Freiburg, 79106, Germany
Completed	Kent Oncology Centre	Maidstone, ME16 9QQ, United Kingdom
Terminated	North Shore University Hospital	Manhasset, 11030-3876, United States
Terminated	New York Medical College	Valhalla, 10595, United States
Completed	Mt. Sinai Comprehensive Cancer Center	Miami Beach, 33140, United States
Completed	Medical College of Wisconsin	Milwaukee, 53226, United States
Completed	West Clinic	Memphis, 38120, United States
Terminated	Cleveland Clinic	Cleveland, 44195, United States
Terminated	University of Washington Medical Center	Seattle, 98195, United States
Completed	University of Chicago	Chicago, 60637, United States
Completed	Cross Cancer Institute	Edmonton, T6G 1Z2, Canada
Completed	Vrije Universiteit Medisch Centrum	AMSTERDAM, 1081 HV, Netherlands
Terminated	Montefiore Medical Center	Bronx, 10467-2490, United States
Completed	Addenbrookes Hospital	Cambridge, CB2 0QQ, United Kingdom
Completed	Charité Campus Benjamin Franklin	Berlin, 12200, Germany
Completed	Hôtel Dieu - Paris	PARIS, 75151, France
Completed	HemOnCare, PC	Brooklyn, 11235-3518, United States
Terminated	The Cancer Institute of New Jersey	New Brunswick, 08903-2681, United States
Completed	Upstate Medical University	Syracuse, 13210-2399, United States

Trial design

An Open Phase II, Multi Center Trial of BAY 59-8862 in Patients with Aggressive, Refractory Non-Hodgkin's Lymphoma

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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