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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00062244 |
RATIONALE: Biological therapies such as oblimersen may interfere with the growth of the cancer cells and slow or stop the growth of Waldenstrom's macroglobulinemia.
PURPOSE: This phase I/II trial is studying the side effects and best dose of oblimersen and to see how well it works in treating patients with relapsed or refractory Waldenstrom's macroglobulinemia.
Condition | Intervention | Phase |
Lymphoma |
Drug: oblimersen |
Phase I Phase II |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Cancer Lymphoma |
ChemIDplus related topics: | Oblimersen sodium |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Study of G3139 (Genasense) in Patients With Waldenstrom's Macroglobulinemia |
Study Start Date: | May 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study.
Cohorts of 1-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A maximum of 61 patients will be accrued for this study within approximately 3.2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of Waldenstrom's macroglobulinemia (WM) confirmed by both of the following:
Symptomatic relapsed or refractory disease requiring therapy, defined by at least 1 of the following:
Impaired bone marrow function due to disease infiltration as demonstrated by any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No active symptoms of coronary artery disease, including the following:
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Arizona | |||||
Mayo Clinic Scottsdale | |||||
Scottsdale, Arizona, United States, 85259 | |||||
United States, District of Columbia | |||||
Howard University Cancer Center at Howard University Hospital | |||||
Washington, District of Columbia, United States, 20060 | |||||
United States, Florida | |||||
Mayo Clinic - Jacksonville | |||||
Jacksonville, Florida, United States, 32224 | |||||
United States, Maryland | |||||
Greenebaum Cancer Center at University of Maryland Medical Center | |||||
Baltimore, Maryland, United States, 21201-1592 | |||||
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||||
Baltimore, Maryland, United States, 21231 | |||||
United States, Minnesota | |||||
Mayo Clinic Cancer Center | |||||
Rochester, Minnesota, United States, 55905 | |||||
United States, Wisconsin | |||||
University of Wisconsin Comprehensive Cancer Center | |||||
Madison, Wisconsin, United States, 53792-5256 |
Mayo Clinic |
National Cancer Institute (NCI) |
Study Chair: | Morie A. Gertz, MD | Mayo Clinic |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000304634, MAYO-MC0285, NCI-5826 |
First Received: | June 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00062244 |
Health Authority: | United States: Federal Government |
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