OraTest in Combination With Visual Examination and Visual Examination Alone

NCT00537199 | Terminated Phase 3 Results

• 1 other identifier: 2005-1008
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 1.To assess the ratio in sensitivities of OraTest® in combination with visual examination versus visual examination alone in the detection of serious pathology defined as severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors.
2. 2.To estimate the adjusted specificity of OraTest® in combination with visual examination in the detection of severe dysplasia, CIS, or cancer of the O/OP cavity.
3. 3.To assess the ratio of sensitivity of OraTest® in combination with visual examination versus visual examination alone in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors.
4. 4.To obtain the adjusted specificity of OraTest® in combination with visual examination in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS or cancer of the O/OP cavity.
5. 5.To evaluate the chromosomal status of the positively staining lesions with respect to 3p, 9p, or 17p deletions.
6. 6.To carry out gene expression studies on biopsies and map these onto an analysis of the widespread chromosomal imbalances in stain-positive and stain-negative lesions.
7. 7.To evaluate the quantitative and qualitative toxicities, as well as other safety parameters, of tolonium chloride 5 mg/mL (OraTest®).

Conditions

Head And Neck Cancer; Oropharynx Cancer

Keywords

Head And Neck; Oropharynx; Oral Cancer; OraTest; OraTest Dye; Rinse Staining Procedure; Visual Examination

Outcome Measures

Primary Outcomes (1)

• Ratio (Percentage) of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone

  Primary efficacy parameters, ratio of sensitivity of OraTest® in combination with visual exam versus visual exam alone is the difference between the adjusted specificity for OraTest in combination with visual exam and the adjusted specificity for visual exam alone. Reported ratio as percentage of patients with abnormalities (suspicious lesions) found upon visual exam of the mouth with and without OraTest® dye.

  Following two (2) scheduled visits for visual examination, up to one month following first exam

Study Arms (1)

OraTest + Visual Exam

OTHER

OraTest dye

Other: Visual Examination; Drug: OraTest

Interventions

Visual Examination OTHER

Two (2) scheduled visits for visual examination of mouth for abnormal lesions and glands in the neck.

OraTest + Visual Exam

OraTest DRUG

Two (2) scheduled visits for rinse staining: 2 teaspoons of OraTest for 20 seconds, then spit.

Also known as: OraTest Dye, Rinse Staining Procedure

OraTest + Visual Exam

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High risk of oral cancer as defined by a twenty-pack/year cigarette smoking history or equivalent and is either a current smoker or has quit smoking within the last 24 months. Twenty-pack/year equivalent is defined as ½ pack/day for 40 years, or one pack/day for 20 years, or 2 packs/day for 10 years, or 4 packs/day for 5 years. AND/OR;
• Ten-year history of twenty orally-consumed alcohol units/week and is either a current drinker or has quit drinking within the last 24 months. Twenty orally-consumed alcohol units/week is defined as the equivalent of twenty - 1 ounce shots of whisky or spirits/week (20 ounces = 600 mL), or twenty - 3 ounce glasses of wine/week (60 ounces = 1800 mL), or twenty - 12 ounce glasses of beer/week (240 ounces = 7200 mL);
• Male or female, at least 45 years of age;
• Written informed consent.
• Females of childbearing potential may be enrolled following a negative urine pregnancy test performed at the SE visit. Abstinence will be considered an acceptable form of birth control.

You may not qualify if:

• History of oral cancer, surgery or biopsy for suspected oral neoplasm;
• History of recent oral surgery, periodontal treatment, or oral trauma (\<14 days) or current orthodonture (e.g., braces);
• Known hypersensitivity to study drug or its analogs;
• Active and uncontrolled infection or any other severe concurrent disease that in the judgment of the investigator would make the patient inappropriate for entry into this study;
• Psychiatric disorders which would interfere with informed consent or follow-up;
• Use of any investigational agent within previous 30 days;
• Female that is lactating or demonstrating positive pregnancy test;
• Patients in whom betel nut use/abuse has been reported within the past 5 years;
• Patients currently taking medication containing prohibited dyes.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Zila Biotechnology, Inc.: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms; Mouth Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Limitations and Caveats

Early termination by sponsor resulted in only 1 patient enrolled and no analysis.

Results Point of Contact

• Title: Mark Chambers, MS, DMD / Professor
• Organization: UT MD Anderson Cancer Center

713-792-6510

Study Officials

• Mark Chambers, DMD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2007
• First Posted: September 28, 2007
• Study Start: November 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 13, 2016
• Results First Posted: January 18, 2010

Record last verified: 2009-12

Locations

US (1)