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Phase II Trial of Allovectin-7® for Head and Neck Cancer

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00050388
Enrollment
Unknown
Registered
2002-12-09
Start date
Unknown
Completion date
2002-06-30
Last updated
2008-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma of the Head and Neck, Head and Neck Cancer, Head and Neck Neoplasms, Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Keywords

Cancer, Carcinoma, Neoplasm, Head cancer, Neck cancer, Tongue cancer, Lip cancer, Oral Cavity, Oropharynx, Pharynx, Larynx, Squamous Cell, Salivary Glands, Tumor, Lesion, Cancer treatment, Clinical trial, Allovectin-7®, Otorhinolaryngologic Neoplasm, Otolaryngologic Cancer, Gene therapy, Immunotherapy, Cancer research, Cancer vaccine, Cancer cells

Brief summary

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.

Detailed description

Treatment - If you take part in this trial you will be treated for about four weeks. You will receive an injection of Allovectin-7® by needle, directly into your tumor. This will be repeated 14 days later. The injections may be given in a doctor's office. A week later, you will undergo surgery to remove the tumor. Your tumor will be measured before Allovectin-7® treatment and before surgery to see if Allovectin-7® was effective in shrinking it. This will be done by general physical exams and scans (such as X-ray scans). There will also be tests on the removed tumor to see if Allovectin-7® helped to boost the immune system to attack the cancer.

Interventions

Sponsors

Vical
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria. * You have been diagnosed with head and neck cancer (also called squamous cell carcinoma of the mouth) * You have Stage I or Stage II disease (a single mouth tumor which has not spread to other areas of the body) * Surgery to remove your tumor is recommended * You have not received any prior therapy for head and neck cancer (e.g. radiation or chemotherapy) * You are able to carry out your normal daily activities

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026