A controlled trial of intratumoral ONYX-015, a selectively-replicating adenovirus, in combination with cisplatin and 5-fluorouracil in patients with recurrent head and neck cancer

F Khuri, J Nemunaitis, I Ganly, J Arseneau, I Tannock, L Romel, M Gore, J Ironside, Robert Hugh MacDougall, C Heise, B Randlev, A M Gillenwater, P Bruso, S B Kaye, W K Hong, D H Kirn

Research output: Contribution to journalArticlepeer-review

1030 Citations (Scopus)

Abstract

ONYX-015 is an adenovirus with the E1B 55-kDa gene deleted, engineered to selectively replicate in and lyse p53-deficient cancer cells while sparing normal cells. Although ONYX-015 and chemotherapy have demonstrated anti-tumoral activity in patients with recurrent head and neck cancer, disease recurs rapidly with either therapy alone. We undertook a phase II trial of a combination of intratumoral ONYX-015 injection with cisplatin and 5-fluorouracil in patients with recurrent squamous cell cancer of the head and neck. There were substantial objective responses, including a high proportion of complete responses. By 6 months, none of the responding tumors had progressed, whereas all non-injected tumors treated with chemotherapy alone had progressed. The toxic effects that occurred were acceptable. Tumor biopsies obtained after treatment showed tumor-selective viral replication and necrosis induction.

Original languageEnglish
Pages (from-to)879-885
Number of pages7
JournalNature Medicine
Volume6
Issue number8
DOIs
Publication statusPublished - Aug 2000

Keywords

  • TUMOR-NECROSIS-FACTOR
  • SQUAMOUS-CELL CARCINOMA
  • HIGH-DOSE CISPLATIN
  • 5-FU INFUSION
  • PHASE-III
  • CHEMOTHERAPEUTIC-AGENTS
  • MONOCLONAL-ANTIBODIES
  • PHARMACOKINETIC MODEL
  • ONCOLOGY-GROUP
  • P53

Fingerprint

Dive into the research topics of 'A controlled trial of intratumoral ONYX-015, a selectively-replicating adenovirus, in combination with cisplatin and 5-fluorouracil in patients with recurrent head and neck cancer'. Together they form a unique fingerprint.

Cite this