Abstract
Background:
The human monoclonal antibody SK-1 recognizes a glycoprotein expressed on the majority of colon cancer tissues. In the current study, we evaluated the safety, toxicity and preliminary efficacy of escalating dosages of SK-1 in patients with advanced colon cancer.
Patients and methods:
SK-1 was administered intravenously at 2, 4 or 10 mg three times to three groups of patients with recurrent colon cancer. The clinical outcome and the induction of serum anti-idiotypic antibody (Ab2) were assessed periodically.
Results:
The mean rate of serum CEA level increase declined significantly during the eight weeks following the treatment. In four patients, serum titer of anti-idiotypic IgG antibodies to SK-1 (Ab2) continued to increase following the treatment.
Conclusion:
HuMAb SK-1 was well-tolerated and can be safely administered. It was suggested that SK-1 natural antibody not only possessed direct cytostatic activity against colon carcinoma, but may also have induced carcinoma-related, anti-idiotypic antibody responses.
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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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adenocarcinoma / blood
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Adenocarcinoma / immunology
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Adenocarcinoma / pathology
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Adenocarcinoma / secondary
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Adenocarcinoma / surgery
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Adenocarcinoma / therapy*
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Adult
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Aged
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Animals
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Antibodies, Anti-Idiotypic / immunology
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Antibodies, Monoclonal / immunology
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Antibodies, Monoclonal / therapeutic use*
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Antibodies, Neoplasm / therapeutic use*
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Antibody Specificity
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Antigens, Neoplasm / immunology*
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Biomarkers, Tumor / blood
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Carcinoembryonic Antigen / blood
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Colorectal Neoplasms / blood
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Colorectal Neoplasms / immunology
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Colorectal Neoplasms / pathology
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Colorectal Neoplasms / surgery
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Colorectal Neoplasms / therapy*
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Female
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Glycoproteins / immunology
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Humans
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Immune Sera
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Immunization, Passive*
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Immunoglobulin Fab Fragments / immunology
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Male
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Mice
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Middle Aged
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Neoplasm Metastasis / therapy
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Neoplasm Proteins / blood
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Neoplasm Proteins / immunology
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Neoplasm Recurrence, Local / blood
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Neoplasm Recurrence, Local / therapy
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Rabbits
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Safety
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Salvage Therapy
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Treatment Outcome
Substances
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Antibodies, Anti-Idiotypic
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Antibodies, Monoclonal
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Antibodies, Neoplasm
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Antigens, Neoplasm
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Biomarkers, Tumor
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Carcinoembryonic Antigen
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Glycoproteins
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Immune Sera
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Immunoglobulin Fab Fragments
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Neoplasm Proteins