A phase I trial of intraperitoneal recombinant gamma-interferon in advanced ovarian carcinoma Journal Article


Authors: D'Acquisto, R.; Markman, M.; Hakes, T.; Rubin, S.; Hoskins, W.; Lewis, J. L. Jr
Article Title: A phase I trial of intraperitoneal recombinant gamma-interferon in advanced ovarian carcinoma
Abstract: The interferons are a class of biological agents that have demonstrated antineoplastic activity in a variety of tumors both in vitro and in vivo. Previous reports have suggested that interferons can be safely administered by the intraperitoneal (IP) route with a pharmacokinetic advantage for peritoneal cavity exposure compared with the systemic circulation and with objective antitumor activity being demonstrated. On the basis of these reports and laboratory data suggesting activity for recombinant γ-interferon (r-GIFN) against several malignant cell lines, we treated 27 refractory ovarian carcinoma patients, including six with very-small volume residual disease, with this agent delivered by the IP route. While r-GIFN was found to be remarkably well tolerated, with a 150- to 200-fold pharmacokinetic advantage for peak levels achieved in the peritoneal cavity compared with the plasma, no objective responses were observed. Despite the lack of demonstrated activity for single-agent IP-administered r-GIFN in this clinical setting, there remains considerable interest in this agent when delivered by the IP route because of in vitro data suggesting concentration-dependent synergy between r-GIFN and other biological agents.
Keywords: clinical article; myalgia; age; fever; gamma interferon; ovary carcinoma; phase 1 clinical trial; lethargy; influenza; recombinant interferon; intraperitoneal drug administration; human; female; priority journal
Journal Title: Journal of Clinical Oncology
Volume: 6
Issue: 4
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1988-04-01
Start Page: 689
End Page: 695
Language: English
DOI: 10.1200/jco.1988.6.4.689
PUBMED: 3128649
PROVIDER: scopus
DOI/URL:
Notes: Article -- Source: Scopus
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MSK Authors
  1. William Hoskins
    255 Hoskins
  2. Thomas B Hakes
    115 Hakes
  3. John   Lewis
    132 Lewis
  4. Maurie Markman
    124 Markman
  5. Stephen C. Rubin
    112 Rubin