MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma

NCT ID: NCT00706238

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-29
• Study Completion Date: 2011-01-19

Brief Summary

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GSK1203486A Group

Patients received 4 cycles of MAGE-A3 product as follows:

• Cycle 1: 6 doses, each given at a 2-week interval,
• Cycle 2: 6 doses, each given at a 3-week interval
• Cycle 3: 4 doses, each given at a 6-week interval
• Cycle 4: 4 doses, each given at a 3-month interval followed by 4 doses, each given at a 6-month interval.

The MAGE-A3 product was administered intramuscularly in the deltoid or lateral regions of the thighs, alternately on the right and left sides.

Group Type: EXPERIMENTAL

GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A

Intervention Type: BIOLOGICAL

IM administration in the deltoid or lateral regions of the thighs, alternately on the right and left sides.

Interventions

GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A

IM administration in the deltoid or lateral regions of the thighs, alternately on the right and left sides.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

CABA, Buenos Aires, Argentina

GSK Investigational Site

Quilmes, Buenos Aires, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Oslo, , Norway

Countries

Argentina; Greece; Norway

Other Identifiers

2007-005203-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

110551

Identifier Type: -

Identifier Source: org_study_id