NCT00064103

Brief Summary

This phase I/II trial is studying the side effects and best dose of gene therapy and to see how well it works in preventing cancer in patients with premalignant carcinoma of the oral cavity or pharynx. Inserting the p53 gene into a person's tumor cells may improve the body's ability to kill the tumor cells

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2003

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

4.2 years

First QC Date

July 8, 2003

Last Update Submit

January 22, 2013

Conditions

Lip and Oral Cavity CancerOropharyngeal CancerStage 0 Lip and Oral Cavity CancerStage 0 Oropharyngeal CancerTongue Cancer

Outcome Measures

Primary Outcomes (4)

  • Frequency of adverse events

    Up to 15 years

  • Severity of adverse events graded using the CTCAE version 3.0

    Up to 15 years

  • Maximum tolerated dose of Ad5CMV-p53 gene

    Evaluated by the frequency and relationship of dose-limiting toxicities, if any, experienced by patients during dose escalation.

    6 months

  • Pharmacodynamics evaluated by examining the injected precancerous lesion for induction of apoptosis and expression of the p53 protein

    Presented using descriptive statistics, frequency tabulations, and graphical displays over time by treatment cohort.

    168 days

Study Arms (1)

Treatment (Ad5CMV-p53 gene)

EXPERIMENTAL

Phase I: Patients receive Ad5CMV-p53 gene by intramucosal injection into the area of the lesion followed at least 2 hours later by Ad5CMV-p53 gene as an oral rinse on day 1. Patients then receive Ad5CMV-p53 gene as an oral rinse twice daily on days 2-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of Ad5CMV-p53 gene as an oral rinse until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Phase II: Patients receive treatment with intramucosal Ad5CMV-p53 gene as in phase I and Ad5CMV-p53 gene as an oral rinse at the MTD.

Biological: Ad5CMV-p53 geneOther: laboratory biomarker analysis

Interventions

Ad5CMV-p53 geneBIOLOGICAL

Given intramucosally or as oral rinse

Also known as: Ad5CMV-p53, ADVEXIN, INGN-201
Treatment (Ad5CMV-p53 gene)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (Ad5CMV-p53 gene)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed mild to moderate dysplasia OR severe dysplasia/carcinoma in situ of the oral cavity or oral pharynx
  • Clinically evident diffuse premalignant disease, defined by 1 of the following mucosal abnormalities:
  • Extension between adjacent organ structures (e.g., lateral tongue, ventral tongue, and the floor of the mouth)
  • Extensive surface area, including the entire ventral tongue or floor of the mouth or buccal mucosa, in a velvety "indiscreet" pattern
  • Meets 1 of the following criteria:
  • Previously treated with conventional treatment (e.g., radiotherapy or surgery) for a prior head and neck malignancy
  • Failed biochemoprevention approaches for premalignant disease
  • Failed other therapeutic approaches for premalignant disease
  • No active squamous cell carcinoma of the head and neck
  • Performance status - Karnofsky 70-100%
  • Absolute granulocyte count at least 2,000/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 1.0 mg/dL
  • Creatinine no greater than 1.5 mg/dL
  • No hypertension (baseline blood pressure 140/90 mm Hg or higher)
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Mouth NeoplasmsOropharyngeal NeoplasmsTongue Neoplasms

Interventions

advexin

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesOtorhinolaryngologic DiseasesTongue Diseases

Study Officials

  • Gary L. Clayman

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2003

First Posted

July 9, 2003

Study Start

June 1, 2003

Primary Completion

August 1, 2007

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)