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Treatment of advanced pancreatic cancer with opioid growth factor: phase I
Jill P Smith1, Robert L Conter, Sandra I Bingaman
1Department of Medicine, Pennsylvania State University College of Medicine, Hershey, PA 17033, USA. jsmith2@psu.edu
Abstract:
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 i.v. to determine the MTD. The s.c. 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 i.v. Due to limited solubility of OGF in small volumes, a maximum dose of 50 microg/kg twice daily was determined by the s.c. 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 i.v. or s.c. routes. During the chronic i.v. phase, two subjects had resolution of liver metastases and one showed regression of the pancreatic tumor. Mean survival from the time of diagnosis was 8.7 months (range 2-23 months) in the i.v. group and 9.5 months (range 1-18 months) in the s.c. 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.
Insights
Opioid growth factor (OGF) shows promise as a safe treatment for advanced pancreatic cancer. Phase I trials indicate OGF is well-tolerated, with some patients experiencing tumor regression and improved survival rates.
Area of Science:
- Oncology
- Pharmacology
- Cancer Biology
Background:
- Opioid growth factor (OGF) is an endogenous pentapeptide with demonstrated inhibitory effects on human pancreatic cancer cell growth in vitro and in vivo.
- Advanced unresectable pancreatic cancer remains a significant clinical challenge with limited effective treatment options.
Purpose of the Study:
- To establish the maximum tolerated dose (MTD) of OGF.
- To determine the safety and toxicity profile of OGF in patients with advanced pancreatic cancer.
- To evaluate both intravenous (i.v.) and subcutaneous (s.c.) routes of administration.
Main Methods:
- A Phase I clinical trial involving escalating doses of OGF administered intravenously (i.v.) over 30 minutes to determine the MTD.
- Evaluation of the subcutaneous (s.c.) route of administration.
- Chronic administration of OGF at the established MTD to monitor safety and toxicity.
- Assessment of adverse events, including vital signs, oxygen saturation, cardiac rhythm, laboratory values, and neurological status.
Main Results:
- Hypotension was identified as the dose-limiting toxicity, establishing the MTD at 250 microg/kg i.v.
- Due to solubility limitations, the maximum s.c. dose was determined to be 50 microg/kg twice daily.
- No significant adverse events were reported for oxygen saturation, cardiac rhythm, laboratory values, or neurological status across both administration routes.
- During chronic i.v. treatment, two patients showed resolution of liver metastases, and one patient experienced pancreatic tumor regression.
- Mean survival was 8.7 months (range 2-23) for the i.v. group and 9.5 months (range 1-18) for the s.c. group.
Conclusions:
- Opioid growth factor (OGF) can be safely administered to patients with advanced pancreatic cancer via both i.v. and s.c. routes.
- Preliminary evidence suggests potential anti-tumor activity, including tumor regression and resolution of metastases.
- Further research is warranted to evaluate the efficacy of OGF as a standalone therapy or in combination with existing treatments for pancreatic cancer.
