Randomized, open phase II study of immunization with the recombinant MAGE-3 protein combined with adjuvant AS02B or AS15 in patients with unresectable and progressive metastatic cutaneous melanoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

Inclusion Criteria

1.The patient has histologically proven measurable metastatic cutaneous melanoma.
Patients with any skin, soft-tissue or lymph-node metastasis can be included in the study, provided the disease is not amenable to curative treatment with surgery. In terms of AJCC 2001 classification, this means that patients with unresectable stage III melanoma or with stage IV M1a melanoma are candidates for inclusion, whereas patients with stage IV M1b or IV M1c disease cannot be included in the study.
The patient must present a documented progressive disease within 12 weeks before the first vaccine administration.
2.The tumor sample expresses the MAGE-3 gene, as determined by RT-PCR analysis (more than 1% of the positive MAGE-3 control included in the assay).
3.The patient is at least 18 years old.
4.If the patient is a woman of childbearing potential, the urine pregnancy test should be done = 1 week before randomization and should be negative.
5.If the patient is a woman of childbearing potential, she must consent to use oral contraception or an IUD during the treatment and until three months have elapsed after the last injection.
6.No previous systemic chemotherapy, except isolated limb perfusion which should be performed > 4 weeks from randomization.
7.No previous vaccine containing a MAGE 3 antigen, and no previous vaccine for the metastatic stage.
Prior adjuvant vaccine containing other tumor antigen than MAGE-3 is allowed if the last vaccine has been injected eight weeks before the randomization.
8.Patient fully recovered from any previous surgery/biopsy.
9.ECOG performance status of 0 or 1.
10.The patient has normal organ functions as shown by all of the following:
•Hemoglobin=Lower Limit of Normal (LLN)
•Leucocytes=Lower Limit of Normal (LLN)
•Lymphocytes=Lower Limit of Normal (LLN)
•Platelets=Lower Limit of Normal (LLN)
•Serum creatinine=Upper Normal Limit (UNL)
•Serum bilirubin=Upper Normal Limit (UNL)
•LDH=Upper Normal Limit (UNL)
•ASAT= 2 ? Upper Normal Limit (UNL)
•ALAT=2 ? Upper Normal Limit (UNL)
•Prothrombin time (PT) within the Central laboratory’s normal range
•Activated partial thromboplastin time (APTT) within the Central laboratory 's normal range
11.Viral tests:
•HIV (human immunodeficiency virus): antibody test should be negative.
•HBV (hepatitis B virus): antigen test should be negative, whereas antibody test may be positive.
•HCV (hepatitis C virus): antibody test should be negative.
12.The patient has not received an organ allograft.
13.Absence of autoimmune diseases (vitiligo is not an exclusion criterion).
Patients without any clinical evidence of autoimmune disease but with a titer of Anti-Nuclear Antibody (by immunofluorescence on Hep2 cells) ? 1/320 or = 1/160 but with auto-antibodies directed against specific auto-antigens (by immunodot and/or ELISA) are not eligible.
14.Absence of immunodeficiency.
15.Patients should not receive anti-cancer treatment(s) during the study period such as chemotherapeutic agents, immune modulating agents such as BCG or immunosuppressive agents such as corticosteroids (except for prednisone, or equivalent, < 0.5 mg/kg/day [absolute maximum 40 mg/day, maximum duration of treatment 3 weeks], inhaled and topical steroids, which are allowed).
16.Absence of splenectomy and/or radiation therapy to the spleen.
17.Absence of any second malignancy(ies) in the previous 5 years, with the exception of surgically cured carcinoma in-situ of the cervix and

Exclusion Criteria

see above

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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