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MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma
This study is currently recruiting participants.
Verified by GlaxoSmithKline, December 2008
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00706238
  Purpose

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

MedlinePlus related topics: Cancer Melanoma
U.S. FDA Resources
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of ASCI-related grade 3 / 4 adverse events (CTCAE version 3 criteria) [ Time Frame: During the whole study. ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events. [ Time Frame: During the whole study. ] [ Designated as safety issue: Yes ]
  • The rate of objective clinical response. [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The rate of stable disease. [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]
  • The rate of mixed response. [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]
  • Time to study treatment failure. [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]
  • Progression-free survival. [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]
  • Progression-free survival after initial SPD. [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]
  • Documentation of any toxicity. [ Time Frame: During the whole study. ] [ Designated as safety issue: Yes ]
  • Immunogenicity at defined time points. [ Time Frame: At 13 defined time points. ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patient with histologically proven, measurable metastatic cutaneous melanoma, and with documented progressive disease within the 12 weeks before the first administration of study treatment.
  • Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.
  • Patient is >= 18 years of age at the time of signature of the informed consent.
  • The patient's tumor shows expression of MAGE-A3 gene
  • ECOG performance status of 0 or 1.
  • The patient has normal organ functions
  • If the patient is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the injection series.
  • In the view of the investigator, the patient can and will comply with the requirements of the protocol.

Exclusion Criteria:

  • The patient has at any time received systemic (bio-)chemotherapy (except for isolated limb perfusion, as long as this was performed at least 4 weeks before first study treatment administration).
  • The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy and immunomodulating agents.
  • The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
  • The patient received any cancer immunotherapeutic containing a MAGE-A3 antigen or any cancer immunotherapeutic for his/her metastatic disease.
  • The patient has received any investigational or non-registered drug or vaccine other than the study medication within the 30 days preceding the first ASCI injection or it is planned that (s)he will receive such a drug during the study period.
  • The patient has (or has had) previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
  • History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
  • The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
  • The patient has a family history of congenital or hereditary immunodeficiency.
  • The patient is known to be positive for the Human Immunodeficiency Virus (HIV).
  • The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
  • The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
  • For female patients: the patient is pregnant or lactating.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706238

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Locations
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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

Keywords provided by GlaxoSmithKline:
Antigen-Specific Cancer Immunotherapeutic,
Melanoma,
metastatic,
tumor antigen,
MAGE-A3
ASCI

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Melanoma, familial
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009