Abstract
Fifty-seven patients with MAGE-3-positive measurable metastatic cancer, most of them with melanoma, were vaccinated with escalating doses of a recombinant MAGE-3 protein combined with a fixed dose of the immunological adjuvant SBAS-2, which contained MPL and QS21. The immunisation schedule included 4 intramuscular (i.m.) injections at 3-week intervals. Patients whose tumour stabilised or regressed after 4 vaccinations received 2 additional vaccinations at 6-week intervals. The vaccine was generally well tolerated. Among the 33 melanoma patients who were evaluable for tumour response, we observed 2 partial responses, 2 mixed responses and 1 stabilisation. Time to progression in these 5 patients varied from 4 to 29 months. In addition, a partial response lasting 10 months was observed in 1 of the 3 metastatic bladder cancer patients included. None of the tumour responses described above involved visceral metastases. Immunological responses to the vaccine will be reported separately.
Publication types
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Clinical Trial
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Clinical Trial, Phase I
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Clinical Trial, Phase II
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Research Support, Non-U.S. Gov't
MeSH terms
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Adjuvants, Immunologic / administration & dosage*
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Adult
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Aged
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Antigens, Neoplasm / administration & dosage*
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Cancer Vaccines / administration & dosage
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Carcinoma, Non-Small-Cell Lung / therapy
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Carcinoma, Transitional Cell / therapy
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Female
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Humans
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Immunization
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Lipid A / administration & dosage
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Lipid A / analogs & derivatives
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Lung Neoplasms / therapy
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Male
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Melanoma / therapy
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Middle Aged
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Neoplasm Metastasis
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Neoplasm Proteins / administration & dosage*
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Neoplasms / pathology
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Neoplasms / therapy*
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Recombinant Proteins / administration & dosage
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Saponins / administration & dosage
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Skin Neoplasms / therapy
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Survival Analysis
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Treatment Outcome
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Urinary Bladder Neoplasms / therapy
Substances
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Adjuvants, Immunologic
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Antigens, Neoplasm
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Cancer Vaccines
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Lipid A
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MAGEA3 protein, human
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Neoplasm Proteins
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Recombinant Proteins
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Saponins
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adjuvant SBAS-2