Clinical trial NCT00706238: MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma
Official title: Study of GSK1203486A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Melanoma
Keywords: metastatic,
Melanoma,
Antigen-Specific Cancer Immunotherapeutic,
ASCI
MAGE-A3
tumor antigen,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Subjects With Any Antigen-Specific Cancer Immunotherapeutic (ASCI) Related Grade 3/4 Adverse Events (AE)
timeFrame: During the entire study, up to 2.5 years per patient
measure: Number of Subjects With Any Serious Adverse Events (SAEs).
timeFrame: During the entire study, up to 2.5 years per patient
measure: The Rate of Objective Clinical Response.
timeFrame: At the time of analysis.
Secondary outcomes:
measure: The Rate of Stable Disease.
timeFrame: At the time of analysis.
measure: The Rate of Mixed Response.
timeFrame: At the time of analysis.
measure: Time to Study Treatment Failure.
timeFrame: At the time of analysis.
measure: Progression-free Survival.
timeFrame: At the time of analysis.
measure: Progression-free Survival After Initial SPD.
timeFrame: At the time of analysis.
measure: Documentation of Any Toxicity.
timeFrame: During the entire study, up to 2.5 years per patient
measure: Immunogenicity at Defined Time Points.
timeFrame: At 13 defined time points.
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Quilmes
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: GSK Investigational Site
state: Santa Fe
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: