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Sponsored by: |
Theradex |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00039156 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: ortataxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive refractory non-Hodgkin's lymphoma (NHL) of one of the following classifications, and for which chemotherapy is deemed appropriate:
At least 1 bidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No history of seizure disorder
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
No more than 3 prior systemic chemotherapy regimens for metastatic NHL:
Endocrine therapy:
Patients with prior parenchymal or meningeal CNS involvement:
Radiotherapy:
Concurrent palliative radiotherapy allowed provided:
Surgery:
Other:
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 | |
Louisiana State University Health Sciences Center - Shreveport | |
Shreveport, Louisiana, United States, 71130-3932 | |
Veterans Affairs Medical Center - Shreveport | |
Shreveport, Louisiana, United States, 71101 | |
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 | |
HemOnCare, P.C. | |
Brooklyn, New York, United States, 11235 | |
New York Medical College | |
Valhalla, New York, United States, 10595 | |
North Shore University Hospital | |
Manhasset, New York, United States, 11030 | |
State University of New York - Upstate Medical University | |
Syracuse, New York, United States, 13210 | |
United States, Tennessee | |
West Clinic | |
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 | |
Canada, Alberta | |
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 |
Study ID Numbers: | CDR0000069358, THERADEX-100389, BAYER-100389, SUNY-HSC-4553 |
Study First Received: | June 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00039156 History of Changes |
Health Authority: | United States: Federal Government |
recurrent grade 3 follicular lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Lymphoma, Mantle-Cell Lymphoma, Follicular Mantle Cell Lymphoma Lymphoblastic Lymphoma Follicular Lymphoma Recurrence Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse |
Burkitt's Lymphoma Lymphatic Diseases Burkitt Lymphoma Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-cell Lymphoma, Non-Hodgkin Aggression Lymphoproliferative Disorders Lymphoma |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |