Journal
INVESTIGATIONAL NEW DRUGS
Volume 20, Issue 3, Pages 327-330Publisher
KLUWER ACADEMIC PUBL
DOI: 10.1023/A:1016270206374
Keywords
arsenic trioxide; metastatic renal cell carcinoma; phase II trial
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Funding
- NCI NIH HHS [5T32-CA-09207-23, K24 CA-82431, CA-0582] Funding Source: Medline
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Fourteen patients with metastatic renal cell carcinoma (RCC) were treated on a Phase II trial with arsenic trioxide (As2O3). Eligible patients had metastatic renal cell carcinoma with bidimensionally measurable disease, a Karnofsky performance status of at least 70%, life expectancy of greater than three months, and no evidence of brain metastases. Arsenic trioxide was given intravenously at a dose of 0.3 mg/kg/day for five consecutive days every four weeks. The most common toxicity observed was grade II elevation in liver function tests (36%), anemia (21%), renal insufficiency (14%), rash (7%), and diarrhea (7%). Best response was stable disease in 3 patients with one patient remaining on study at 8+ months At the dose and schedule used in this trial, arsenic trioxide did not achieve a complete or partial response in metastatic renal cell carcinoma.
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