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Opioid growth factor (OGF) is an endogenous pentapeptide that inhibits growth of human pancreatic cancer cells in culture, as well as xenografts in nude mice . To establish the maximum tolerated dose (MTD), and determine safety and toxicity of OGF, a phase I trial was performed in patients with advanced unresectable pancreatic cancer. Patients with unresectable pancreatic adenocarcinoma were treated with escalating doses of OGF for 30 min . to determine the MTD. The . route of administration also was evaluated. Once the MTD was established, a group of patients was treated chronically, and monitored for safety and toxicity. Hypotension was the dose-limiting toxicity, resulting in a MTD of 250 microg/kg . Due to limited solubility of OGF in small volumes, a maximum dose of 50 microg/kg twice daily was determined by the . route of administration. No adverse events were reported for oxygen saturation, cardiac rhythm, laboratory values or neurological status in either the acute or chronic parts of the study with the . or . routes. During the chronic . phase, two subjects had resolution of liver metastases and one showed regression of the pancreatic tumor. Mean survival from the time of diagnosis was months (range 2-23 months) in the . group and months (range 1-18 months) in the . group. We conclude that OGF can be safely administered to patients with advanced pancreatic cancer. Further studies are needed to determine the efficacy of OGF alone or in combination with present modes of therapy for the treatment of pancreatic cancer.
The cortisol activity of MPA at these high doses is thought to increase serum glucose in rats which reactively stimulates the beta cells of the pancreatic islets to produce insulin. This repeated stimulation is thought to cause the tumours in rats. Similar lesions are not likely to occur in humans since the endocrine system of rats is more sensitive to hormones than that of women. When MPA is combined with estrogen, MPA binds to fewer glucocorticosteriod receptors and thus has less effect on plasma glucose. In humans, the diabetogenic response to MPA at therapeutic doses is slight. Moreover, an extensive literature search revealed no evidence that MPA causes pancreatic tumours in humans.