GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma

TerminadoFase 3ClinicalTrials.gov

ID: NCT00796445Tipo: INTERVENTIONALInicio: 1 de dic de 2008Fin estimado: 27 de ene de 2016

Traducción no disponible, mostrando original

Resumen

The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor. This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Written informed consent signed.
Male or female patient with histologically proven stage IIIB or IIIC cutaneous melanoma presenting with macroscopic lymph node involvement suitable for surgery.
The patient must have been surgically rendered free of disease before the randomization.
Patient is ≥ 18 years old at the time of signing the informed consent form.
The patient's lymph node tumor shows expression of the MAGE-A3 gene.
The patient has fully recovered from surgery.
ECOG performance status of 0 or 1 at the time of randomization.
The patient must have adequate organ functions as assessed by standard laboratory criteria.
If the patient is female, she must be of non-childbearing potential, or practice adequate contraception.
In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol.

Criterios de exclusión

The patient suffers from a mucosal or ocular melanoma.
The patient has or has had any history of in-transit metastases
The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the surgery that qualifies the patient for inclusion in the present trial.
The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.
Use of any investigational or non-registered product (drug or vaccine) other than the study treatment.
The patient has a history of autoimmune disease.
The patient has a family history of congenital or hereditary immunodeficiency.
The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.
History of allergic disease or reactions likely to be exacerbated by any component of the treatments.
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.
The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
The patient has an uncontrolled bleeding disorder.
For female patients: the patient is pregnant or lactating.

Intervenciones

drug

GSK 2132231A

IM solution, a course of 13 injections administered over 27 months

drug

Placebo

IM solution, a course of 13 injections administered over 27 months

Ubicaciones

GSK Investigational Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Cipolletti, Río Negro Province, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

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