A phase I/Ib study of folate immune (EC90 vaccine administered with gpi-0100 adjuvant followed by EC17) with interferon-α and interleukin-2 in patients with renal cell carcinoma

Robert J. Amato, Aditya Shetty, Yingjuan Lu, P. Ron Ellis, Virginia Mohlere, Natalie Carnahan, Philip S. Low

Research output: Contribution to journalArticle

17 Scopus citations

Abstract

Folate immune (EC90 vaccine with GPI-0100 adjuvant followed by EC17) is a novel folate-targeted hapten immunotherapy designed to exploit the overexpression of folate receptors on renal cell carcinoma (RCC) cells. In this open-label, phase I/II clinical study, we report the safety, pharmacokinetics, and antitumor activity of folate immune with concurrent interleukin-2 (IL-2) and interferon-α (IFN-α) in patients with recurrent or metastatic RCC. Twenty-four patients were enrolled. Following 2 phase I cohorts of 6 patients each, we extended the study to 12 additional patients: 18 received weekly vaccination of 1.2 mg of EC90 with 3.0 mg of GPI-0100 adjuvant for 4 weeks. Beginning on cycle 1, day 8, 0.3 mg/kg of EC17 was administered once daily, 5 days per week (Monday-Friday) for 4 consecutive weeks. Beginning on cycle 1, day 15, IL-2 and IFN-α were administered at doses of 12 and 3.0 MIU, respectively, after the EC17 dose, 3 times per week (Monday, Wednesday, and Friday) for 3 weeks. In cycle 2, IL-2 and IFN-α, doses of 7.0 and 3.0 MIU, respectively, were administered 3 days per week (Monday, Wednesday, and Friday) for 4 consecutive weeks. No dose-limiting toxicities were observed. Most adverse events reported were grade 1 or 2, with only twelve grade ≤3 toxicities reported. Sixteen patients had progressive disease, 7 patients were observed to have stable disease, and 1 patient achieved a partial response lasting 71 days. Overall, folate immune plus low-dose IFN-α and IL-2 was safe and well tolerated with some observed clinical activity.

Original languageEnglish (US)
Pages (from-to)237-244
Number of pages8
JournalJournal of Immunotherapy
Volume37
Issue number4
DOIs
StatePublished - May 2014

Keywords

  • Folate immune
  • Immunotherapy
  • Phase I/II study
  • Renal cell carcinoma

ASJC Scopus subject areas

  • Pharmacology
  • Immunology
  • Immunology and Allergy
  • Cancer Research

Fingerprint Dive into the research topics of 'A phase I/Ib study of folate immune (EC90 vaccine administered with gpi-0100 adjuvant followed by EC17) with interferon-α and interleukin-2 in patients with renal cell carcinoma'. Together they form a unique fingerprint.

Cite this