phase ii study to assess the safety and immunogenicity of recmage-a3+as15 asci with or without poly ic:lc

Conditions: Melanoma

Summary: the overall purpose of this research study is to find a better way to treat melanoma. the goals of this study are: 1. to measure the side effects of and find out how well patients tolerate the recmage-a3 + as15 asci (mage-a3 asci) treatment with or without the poly ic:lc 2. to see how well the patient's immune system responds to the mage-a3 asci treatment with or without the poly ic:lc 3. to measure the rate of return of the patient's tumor after the mage-a3 asci treatment with or without the poly ic:lc 4. to measure the rate of return of the patient's tumor in two groups of patients: one group positive for the gene signature, and the other group not positive for the gene signature in their tumor after the mage-a3 asci treatment with or without the poly ic:lc.

in the first year, participants may receive up to 8 injections given in the following order: 1. 5 asci injections with or without poly ic:lc with a 3-week interval between each. 2. 3 asci injections with or without poly ic:lc with a 3-month interval between each. during years 2 through 3, participants may receive up to 5 asci injections with or without poly ic:lc given in the following order: 3. during year 2, asci injections with or without poly ic:lc will be given every 3 months for a total of up to 3 injections. 4. during year 3, asci injections with or without poly ic:lc will continue to be given every 3 months for a total of up to 2 more injections.

Eligibility criteria:
inclusion criteria: * written informed consent for the study will be obtained prior to the performance of mage-a3 expression screening on resected tumor tissue or any other protocol-specific procedure. * male or female patient with histologically proven and completely resected stage iv cutaneous or mucosal melanoma. in terms of the american joint committee on cancer (ajcc) classification \[ajcc, 2009\], this means that patients with resected m1a-b-c (stage iv) disease may be enrolled. * the patient must have been surgically rendered free of disease no more than 12 weeks before the randomization. * patient is equal to or greater than 18 years old at the time of signing the informed consent form. * the patient's tumor shows expression of the mage-a3 gene, as determined by reverse transcriptase polymerase chain reaction (rt-pcr) analysis on paraffin imbedded tumor tissue (ffpe). in all patients in whom it can be obtained, a frozen portion of the resected tumor will be analyzed for gene profiling. * the patient has fully recovered from surgery. * eastern cooperative oncology group (ecog) performance status of 0 or 1 at the time of randomization. * the patient must have adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria: absolute neutrophil count (anc) equal to or greater than 1.5 x 10\^9/l, platelet count equal to or greater than 75 x 10\^9/l, serum creatinine equal to or less than 1.5 times the upper limit of normal (uln), total bilirubin equal to or less than 1.5 times the uln, transaminase (alt - ast) equal to or less than 2.5 times the uln * if the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to randomization, have a negative pregnancy test and continue such precautions during the entire study treatment period and for 2 months after completion of the injection series. * men must also agree to use an adequate method of contraception. * in the opinion of the investigator, the patient can and will comply with all the requirements of the protocol. exclusion criteria: * the patient has an ocular melanoma. * the patient has in-transit metastases. * the patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the metastasectomy that qualifies the patient for inclusion in the present trial. * one prior systemic treatment with an immunomodulator (i.e., interferon, vaccine and/or anti-ctla-4) after a previous surgery is permitted, provided that the last dose has been administered at least 45 days before randomization in the present trial. * previous radiotherapy is permitted, provided that the treatment has been completed before the surgery that qualifies the patient for participation in the present trial. * the patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents. the use of prednisone, or equivalent, at a dose of \< 0.125 mg/kg/day (absolute maximum 10 mg/day) or topical steroids is permitted. * use of any investigational or non-registered product (drug or vaccine) other than the study treatment within 30 days preceding the randomization or planned use during the study period. * the patient has a history of 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 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.

Keywords: resected skin stage iv