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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00849875 |
The purpose of this clinical trial is to find out how successfully, patients with progressive metastatic cutaneous melanoma, are able to develop an immune response to injections with the immunotherapeutic product GSK1572932A when given in combination with dacarbazine and evaluate the safety of this combination.
Condition | Intervention | Phase |
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Malignant Melanoma Neoplasms |
Biological: Immunotherapeutic GSK2132231A Drug: Dacarbazine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Association With Chemotherapy in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma. |
Estimated Enrollment: | 20 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | May 2014 |
Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Single Group: Experimental
All patients are to receive the same treatment consisting of 24 injections of the immunotherapeutic GSK2132231A combined with a course of 8 cycles of dacarbazine given at the beginning of the treatment
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Biological: Immunotherapeutic GSK2132231A
Intramuscular administration
Drug: Dacarbazine
Intravenous administration Chemotherapy
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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 |
Belgium | |
GSK Investigational Site | Recruiting |
Brussels, Belgium, 1200 | |
GSK Investigational Site | Recruiting |
Yvoir, Belgium, 5530 | |
GSK Investigational Site | Recruiting |
Bruxelles, Belgium, 1180 | |
France | |
GSK Investigational Site | Recruiting |
Paris Cedex 10, France, 75475 | |
GSK Investigational Site | Recruiting |
Paris, France, 75018 | |
GSK Investigational Site | Not yet recruiting |
Caen, France, 14033 | |
GSK Investigational Site | Recruiting |
Villejuif, France, 94805 | |
GSK Investigational Site | Recruiting |
Lille, France, 59037 | |
GSK Investigational Site | Recruiting |
Nantes, France, 44093 | |
GSK Investigational Site | Recruiting |
Reims, France, 51092 | |
GSK Investigational Site | Recruiting |
Marseille, France, 13009 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111714 |
Study First Received: | February 2, 2009 |
Last Updated: | August 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00849875 History of Changes |
Health Authority: | Belgium: Agence Fédérale des Médicaments et des Produits de la Santé; France: Agence Française de Sécurité Sanitaire des Produits de Santé |
Malignant melanoma Cancer immunotherapeutic ASCI Dacarbazine MAGE-A3 |
Neuroectodermal Tumors Dacarbazine Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Antineoplastic Agents, Alkylating |
Nevus Alkylating Agents Melanoma, Familial Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Dacarbazine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Pharmacologic Actions Melanoma Neuroendocrine Tumors |
Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents |