A phase I study in paediatric patients to evaluate the safety and pharmacokinetics of SPI-77, a liposome encapsulated formulation of cisplatin
2001

Safety and Pharmacokinetics of SPI-77 in Children with Cancer

publication Evidence: moderate

Author Information

Author(s): Veal G J, Griffin M J, Price E, Parry A, Dick G S, Little M A, Yule S M, Morland B, Estlin E J, Hale J P, Pearson A D J, Welbank H, Boddy A V

Primary Institution: Department of Child Health, Medical School, University of Newcastle-upon-Tyne

Hypothesis

The study aims to evaluate the safety and pharmacokinetics of SPI-77, a liposome-encapsulated formulation of cisplatin, in paediatric patients.

Conclusion

The study found that high doses of liposomal cisplatin can be safely administered to children with advanced cancer, although no treatment responses were observed.

Supporting Evidence

  • SPI-77 was well tolerated with the major toxicity being an infusion reaction.
  • Limited haematological toxicity and no nephrotoxicity were observed.
  • Cisplatin was retained in circulation with a half-life of up to 134 hours.
  • Maximum plasma concentrations were approximately 100-fold higher than those reported for native cisplatin.

Takeaway

Doctors tested a new cancer treatment for kids that uses a special type of medicine that is less harmful, and it seemed safe to use, but it didn't help the kids get better.

Methodology

Paediatric patients received doses of SPI-77 via intravenous infusion every 4 weeks, with blood and urine samples collected for analysis.

Limitations

No treatment responses were observed during the study, indicating the need for further research.

Participant Demographics

Paediatric patients with advanced cancer not amenable to other treatment.

Digital Object Identifier (DOI)

10.1054/bjoc.2001.1723

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