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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00516217 |
RATIONALE: Monoclonal antibodies, such as galiximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PURPOSE: This phase II trial is studying how well galiximab works in treating patients with relapsed or refractory Hodgkin's lymphoma.
Condition | Intervention | Phase |
Lymphoma |
Drug: fludeoxyglucose F 18 Drug: galiximab |
Phase II |
MedlinePlus related topics: | Cancer Hodgkin's Disease Lymphoma |
ChemIDplus related topics: | Fluorodeoxyglucose F18 Galiximab |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma |
Estimated Enrollment: | 56 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients also undergo FDG-PET/CT imaging at baseline and at time of first restaging (within 7 days prior to week 8 treatment).
After completion of study treatment, patients are followed periodically for 10 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed classical Hodgkin lymphoma (HL):
Measurable disease must be present on either physical examination or imaging studies
Evaluable or non-measurable disease alone is not acceptable including any of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent steroids, hormones, or other chemotherapeutic agents except for steroids given for adrenal failure and hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
United States, Delaware | |||||
CCOP - Christiana Care Health Services | Recruiting | ||||
Newark, Delaware, United States, 19713 | |||||
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services 302-733-6227 | |||||
Tunnell Cancer Center at Beebe Medical Center | Recruiting | ||||
Lewes, Delaware, United States, 19958 | |||||
Contact: Clinical Trials Office - Tunnell Cancer Center 302-645-3171 | |||||
United States, Illinois | |||||
University of Chicago Cancer Research Center | Recruiting | ||||
Chicago, Illinois, United States, 60637-1470 | |||||
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |||||
United States, Maryland | |||||
Union Hospital Cancer Program at Union Hospital | Recruiting | ||||
Elkton MD, Maryland, United States, 21921 | |||||
Contact: Stephen S. Grubbs, MD 410-398-4000 | |||||
United States, Missouri | |||||
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting | ||||
Saint Louis, Missouri, United States, 63110 | |||||
Contact: Nancy L. Bartlett, MD 314-362-4843 | |||||
United States, New Jersey | |||||
Cancer Institute of New Jersey at Cooper - Voorhees | Recruiting | ||||
Voorhees, New Jersey, United States, 08043 | |||||
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo 856-325-6757 | |||||
United States, North Carolina | |||||
Kinston Medical Specialists | Recruiting | ||||
Kinston, North Carolina, United States, 28501 | |||||
Contact: Peter R. Watson, MD 252-559-2200 ext. 201 | |||||
Wayne Memorial Hospital, Incorporated | Recruiting | ||||
Goldsboro, North Carolina, United States, 27534 | |||||
Contact: James N. Atkins, MD 919-580-0000 | |||||
United States, Ohio | |||||
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting | ||||
Columbus, Ohio, United States, 43210-1240 | |||||
Contact: Clinical Trials Office - OSU Comprehensive Cancer Center 614-293-4976 osu@emergingmed.com | |||||
United States, Pennsylvania | |||||
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Recruiting | ||||
Pittsburgh, Pennsylvania, United States, 15224-1791 | |||||
Contact: John Lister 412-578-5000 | |||||
United States, Virginia | |||||
Danville Regional Medical Center | Recruiting | ||||
Danville, Virginia, United States, 24541 | |||||
Contact: Clinical Trials Office - Danville Regional Medical Center 434-799-3753 | |||||
Virginia Commonwealth University Massey Cancer Center | Recruiting | ||||
Richmond, Virginia, United States, 23298-0037 | |||||
Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 |
Cancer and Leukemia Group B |
National Cancer Institute (NCI) |
Study Chair: | Sonali M. Smith, MD | University of Chicago |
Investigator: | Nancy L. Bartlett, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000561185, CALGB-50602 |
First Received: | August 14, 2007 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00516217 |
Health Authority: | Unspecified |
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