mage-a3 antigen-specific cancer immunotherapeutic in patients with progressive metastatic cutaneous melanoma

Conditions: Melanoma

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.

Keywords: metastatic, melanoma, antigen-specific cancer immunotherapeutic, asci mage-a3 tumor antigen,