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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
4
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pubmed:dateCreated |
1992-2-27
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pubmed:abstractText |
To determine the maximally tolerated dose of a ricin A chain-conjugated antimelanoma antibody (XomaZyme-Mel), 20 patients with metastatic melanoma were treated with escalating doses of the murine immunotoxin given as single intravenous infusion over 30 minutes. The starting dose was 0.6 mg/kg and was escalated in five groups to a maximum of 1.6 mg/kg. The maximally tolerated dose was 1.25 mg/kg as three of six patients treated at 1.6 mg/kg developed unacceptable toxicity. The dose-limiting toxicity consisted of profound fatigue, myalgias, and arthralgias. These occurred within 4 days and resolved in 7 to 10 days. Other non-dose-limiting toxicities encountered consisted of hypoalbuminemia, weight gain, peripheral edema, mild hypotension, and flu-like syndrome; the severity of these was also dose related. In addition, two allergic reactions occurred, one severe. There was one durable complete response of 12+ months' duration and one brief mixed response lasting 3 months. We conclude that the maximum tolerated single dose of XomaZyme-Mel is 1.25 mg/kg. Phase I studies evaluating 1.25 mg/kg given in multiple doses at 2- to 4-week intervals and phase II studies to determine the response rate of a single 1.25 mg/kg dose are warranted.
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pubmed:grant | |
pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Dec
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pubmed:issn |
0952-8172
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
3
|
pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
192-6
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pubmed:dateRevised |
2007-11-14
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pubmed:meshHeading |
pubmed-meshheading:1768370-Adult,
pubmed-meshheading:1768370-Aged,
pubmed-meshheading:1768370-Animals,
pubmed-meshheading:1768370-Antibodies, Monoclonal,
pubmed-meshheading:1768370-Female,
pubmed-meshheading:1768370-Humans,
pubmed-meshheading:1768370-Immunotoxins,
pubmed-meshheading:1768370-Infusions, Intravenous,
pubmed-meshheading:1768370-Male,
pubmed-meshheading:1768370-Melanoma,
pubmed-meshheading:1768370-Mice,
pubmed-meshheading:1768370-Middle Aged,
pubmed-meshheading:1768370-Ricin
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pubmed:year |
1991
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pubmed:articleTitle |
Single-dose murine monoclonal antibody ricin A chain immunotoxin in the treatment of metastatic melanoma: a phase I trial.
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pubmed:affiliation |
Division of Medical Oncology, University of Colorado Cancer Center, Denver 80262.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Research Support, U.S. Gov't, P.H.S.
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