NCT00050388

Phase II Study of the Safety and Efficacy of Allovectin-7® Immunotherapy for the Treatment of Primary, Resectable Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Completed Phase 3 Last updated 20 June 2008

What this trial tests

Phase 3 trial testing Allovectin-7® in Head and Neck Cancer. Completed in 1 June 2002.

Timeline

1 June 2002

Quick facts

Lead sponsor	Vical
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Estimated completion	1 June 2002
Sites	10 locations across United States

Drugs / interventions tested

• Allovectin-7®

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• Squamous Cell Carcinoma of the Oral Cavity or Oropharynx — all drugs for Squamous Cell Carcinoma of the Oral Cavity or Oropharynx →
• Head and Neck Neoplasms — all drugs for Head and Neck Neoplasms →
• Carcinoma of the Head and Neck — all drugs for Carcinoma of the Head and Neck →

Sponsor

Vical — full company profile →

Who can join

18 and older, any sex, with Head and Neck Cancer or Squamous Cell Carcinoma of the Oral Cavity or Oropharynx. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink head and neck tumors. The trial will also examine if treatment can boost the immune system and if this treatment can improve the time to disease progression.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tumor microenvironment and immunotherapy of oral cancer.
   Liu C, Wang M, Zhang H, Li C, et al · · 2022 · cited 78× · PMID 36209263 · DOI 10.1186/s40001-022-00835-4
2. Engineering Vaccines to Reprogram Immunity against Head and Neck Cancer.
   Tan YS, Sansanaphongpricha K, Prince MEP, Sun D, et al · · 2018 · cited 39× · PMID 29533731 · DOI 10.1177/0022034518764416
3. Immunotherapy Advances in Locally Advanced and Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Its Relationship With Human Papillomavirus.
   Wang H, Zhao Q, Zhang Y, Zhang Q, et al · · 2021 · cited 33× · PMID 34305889 · DOI 10.3389/fimmu.2021.652054
4. Vaccine-Based Immunotherapy for Head and Neck Cancers.
   Beyaert S, Machiels JP, Schmitz S. · · 2021 · cited 29× · PMID 34885150 · DOI 10.3390/cancers13236041
5. Novel Immunotherapeutic Approaches for Head and Neck Squamous Cell Carcinoma.
   Bann DV, Deschler DG, Goyal N. · · 2016 · cited 22× · PMID 27669306 · DOI 10.3390/cancers8100087
6. Oncolytic virus-based suicide gene therapy for cancer treatment: a perspective of the clinical trials conducted at Henry Ford Health.
   Thoidingjam S, Sriramulu S, Freytag S, Brown SL, et al · · 2023 · cited 17× · PMID 37065938 · DOI 10.1186/s41231-023-00144-w
7. Head and Neck Cancer Immunotherapy: Molecular Biological Aspects of Preclinical and Clinical Research.
   Chakraborty R, Darido C, Liu F, Maselko M, et al · · 2023 · cited 13× · PMID 36765809 · DOI 10.3390/cancers15030852
8. Lipid-based nucleic acid therapeutics with in vivo efficacy.
   Sufian MA, Ilies MA. · · 2023 · cited 13× · PMID 36180107 · DOI 10.1002/wnan.1856