OraTest in Combination With Visual Examination and Visual Examination Alone

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objectives:

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. 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.

Secondary Objectives:

1. 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.

2. 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.

3. To evaluate the chromosomal status of the positively staining lesions with respect to 3p, 9p, or 17p deletions.

4. 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.

5. To evaluate the quantitative and qualitative toxicities, as well as other safety parameters, of tolonium chloride 5 mg/mL (OraTest®).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Zila Biotechnology, Inc.

Criteria

Inclusion Criteria:

1. 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;

2. 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);

3. Male or female, at least 45 years of age;

4. Written informed consent.

5. 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.

Exclusion Criteria:

1. History of oral cancer, surgery or biopsy for suspected oral neoplasm;

2. History of recent oral surgery, periodontal treatment, or oral trauma (<14 days) or current orthodonture (e.g., braces);

3. Known hypersensitivity to study drug or its analogs;

4. 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;

5. Psychiatric disorders which would interfere with informed consent or follow-up;

6. Use of any investigational agent within previous 30 days;

7. Female that is lactating or demonstrating positive pregnancy test;

8. Patients in whom betel nut use/abuse has been reported within the past 5 years;

9. Patients currently taking medication containing prohibited dyes.