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Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Patients With Inoperable Metastatic Cutaneous Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00896480
First received: May 7, 2009
Last updated: February 6, 2014
Last verified: August 2013
  Purpose

The clinical objective of this clinical trial is to examine the clinical activity in terms of tumor response and time to treatment failure of the immunotherapeutic product GSK2132231A when given to patients with unresectable and progressive metastatic cutaneous melanoma. The safety of the treatment will also be assessed just as its immunogenicity in terms of the humoral and cellular immune response induced by the GSK2132231A immunotherapeutic. Translational research objectives are to assess the effects of the study treatment in terms of various biological variables.


Condition Intervention Phase
Melanoma
Biological: Immunotherapeutic GSK2132231A
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Activity, Safety and Immunogenic Properties of Cancer Immunotherapeutic GSK2132231A in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Tumor response defined as objective response (complete or partial), stable disease or mixed response [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]
  • Time to treatment failure defined as the interval from the first administration of the study treatment until the patient is withdrawn from treatment [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]
  • Occurrence of Grade 3 or 4 adverse events possibly related to the study treatment [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: At specified time points during the immunization period (20 assessments per patient) and after the concluding visit of the last patient ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single group
Patients will receive a treatment consisting of 24 injections of the experimental GSK2132231A immunotherapeutic
Biological: Immunotherapeutic GSK2132231A
Administration by intramuscular injection
Other Name: MAGE-A3 ASCI

  Eligibility

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

Inclusion Criteria:

  1. The patient (male or female) has histologically proven, measurable metastatic cutaneous melanoma in one of the following stages according to the American Joint Committee on Cancer classification of 2002:

    • Stage III in transit, or
    • Stage III unresectable, or
    • Stage IV M1a.
  2. There has been documented progression of the patient's disease within the 12 weeks before the first administration of study treatment.
  3. The patient presents at screening with at least 3 tumor lesions of diameter >= 0.5 mm.
  4. Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.
  5. The patient is >= 18 years of age at the time of signature of informed consent.
  6. The patient's tumor shows expression of MAGE-A3 gene in at least one of the two tumor biopsies performed at baseline.
  7. The patient's ECOG performance status is 0 or 1.
  8. The patient has normal organ functions, as assessed by standard laboratory criteria.
  9. 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 the entire study treatment period and for 2 months after completion of the treatment injection series.
  10. In the view of the investigator, the patient can and will comply with the requirements of the protocol.

Exclusion Criteria:

  1. The patient has at any time received systemic (bio)-chemotherapy
  2. The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy and immunomodulating agents.
  3. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
  4. The patient has received any cancer immunotherapeutic containing a MAGE A3 antigen or any cancer immunotherapeutic for his/her metastatic disease.
  5. Use of any investigational or non-registered product (drug or vaccine) other than the study treatment within the 30 days preceding the first dose of study treatment, or planned use during the study period.
  6. 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.
  7. History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
  8. The patient has an autoimmune disease such as, but not limited to, neuroinflammatory autoimmune diseases, systemic lupus erythematosus, and inflammatory bowel disease
  9. The patient has a family history of congenital or hereditary immunodeficiency.
  10. The patient is known to be positive for the human immunodeficiency virus (HIV).
  11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.
  12. 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.
  13. For female patients: the patient is pregnant or lactating.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896480

Locations
Belgium
GSK Investigational Site
Brussels, Belgium, 1200
GSK Investigational Site
Bruxelles, Belgium, 1180
GSK Investigational Site
Jette, Belgium, 1090
GSK Investigational Site
Liège, Belgium, 4000
GSK Investigational Site
Wilrijk, Belgium, 2610
GSK Investigational Site
Yvoir, Belgium, 5530
France
GSK Investigational Site
Caen, France, 14033
GSK Investigational Site
Lille, France, 59037
GSK Investigational Site
Paris Cedex 10, France, 75475
GSK Investigational Site
Reims, France, 51092
GSK Investigational Site
Villejuif, France, 94805
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00896480     History of Changes
Other Study ID Numbers: 111473
Study First Received: May 7, 2009
Last Updated: February 6, 2014
Health Authority: Belgium: Agence Fédérale des Médicaments et des Produits de la Santé
France: Agence Française de Sécurité Sanitaire des Produits de Santé

Keywords provided by GlaxoSmithKline:
ASCI (Antigen-Specific Cancer Immunotherapeutic)
MAGE-A3
Malignant melanoma
Cancer immunotherapeutic

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 27, 2014