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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00706238 |
This study is being done to evaluate the safety and the clinical activity of MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in patients with unresectable and progressive metastatic cutaneous melanoma.
Condition | Intervention | Phase |
---|---|---|
MAGE-A3-Positive Unresectable and Progressive Metastatic Cutaneous Melanoma |
Biological: GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Study of GSK1203486A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma |
Estimated Enrollment: | 34 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Biological: GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A
IM administration
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Argentina, Buenos Aires | |
GSK Investigational Site | Not yet recruiting |
Quilmes, Buenos Aires, Argentina, 1878 | |
GSK Investigational Site | Not yet recruiting |
CABA, Buenos Aires, Argentina, C1425DTG | |
GSK Investigational Site | Not yet recruiting |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1185AAT | |
GSK Investigational Site | Withdrawn |
Capital Federal, Buenos Aires, Argentina, C1417DTN | |
Argentina, Santa Fe | |
GSK Investigational Site | Not yet recruiting |
Rosario, Santa Fe, Argentina, 2000 | |
Brazil | |
GSK Investigational Site | Active, not recruiting |
São Paulo, Brazil, 03102-00 | |
GSK Investigational Site | Not yet recruiting |
São Paulo, Brazil, 01308-050 | |
Brazil, Minas Gerais | |
GSK Investigational Site | Not yet recruiting |
Belo Horizonte, Minas Gerais, Brazil, 30150-281 | |
Brazil, Rio Grande Do Sul | |
GSK Investigational Site | Not yet recruiting |
Porto Alegre, Rio Grande Do Sul, Brazil, 90610 000 | |
Greece | |
GSK Investigational Site | Active, not recruiting |
Larisa, Greece, 41110 | |
GSK Investigational Site | Withdrawn |
Athens, Greece, 185 47 | |
GSK Investigational Site | Active, not recruiting |
Athens, Greece, 11527 | |
Norway | |
GSK Investigational Site | Recruiting |
Oslo, Norway, 0310 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110551 |
Study First Received: | June 25, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00706238 |
Health Authority: | Norway: Norwegian Medicines Agency |
Antigen-Specific Cancer Immunotherapeutic, Melanoma, metastatic, |
tumor antigen, MAGE-A3 ASCI |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Melanoma, familial |
Neuroepithelioma Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |