A Phase III Study to Test the Benefit of a New Kind of Anti-Cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00796445

Purpose

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.

Condition	Intervention	Phase
Resected Stage III Melanoma With Macroscopic Involvement	Drug: GSK 2132231A Drug: Placebo	Phase III

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Disease Free Survival [ Time Frame: Once the pre-defined number of events is reached ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Survival [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
Disease-free specific survival [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
Distant metastasis-free survival [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
Anti-MAGE-A3 and anti-protein D seropositivity status. [ Time Frame: Post-treatment and 1 year after concluding visit. ] [ Designated as safety issue: No ]
Occurrence of adverse events including abnormal haematological and biochemical parameters. [ Time Frame: Up to 30 days after each study dose. ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events and autoimmunity events. [ Time Frame: During the whole study duration up to 30 days after the last administration of study treatment. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1300
Study Start Date:	December 2008
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: Placebo Comparator	Drug: Placebo IM solution, a course of 13 injections will be administered over 27 months
Group A: Experimental	Drug: GSK 2132231A IM solution, a course of 13 injections will be administered over 27 months

Eligibility

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

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

The patient suffers from melanoma of non-cutaneous origin.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796445

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 266 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111482
Study First Received:	November 21, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00796445
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
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 15, 2009