OraTest in Combination With Visual Examination and Visual Examination Alone

This study has been terminated.
(Study terminated early as per request by sponsor, Zila Biotechnology, Inc.)
Sponsor:
Collaborator:
Zila Biotechnology
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00537199
First received: September 26, 2007
Last updated: December 11, 2009
Last verified: December 2009
  Purpose

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®).

Condition Intervention Phase
Head and Neck Cancer
Oropharynx Cancer
Other: Visual Examination
Drug: OraTest
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of OraTest in Combination With Visual Examination in the Improved Detection of Oral Mucosal Lesions Suspicious of Serious Pathology in High-Risk Patients for the Purpose of Referral to the Health Care Professional Experienced in Oral Cancer: Phase III Clinical Trial Comparing the Sensitivity and Assessing the Specificity of OraTest in Combination With Visual Examination and Visual Examination Alone in Patients at High Risk as Defined by Age and Lifestyle Factors (ZIL-401)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Ratio of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone [ Time Frame: Two (2) scheduled visits for visual examination. ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: February 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
OraTest + Visual Exam
OraTest dye
Other: Visual Examination
Two (2) scheduled visits for visual examination of mouth for abnormal lesions and glands in the neck.
Drug: OraTest
Two (2) scheduled visits for rinse staining: 2 teaspoons of OraTest for 20 seconds, then spit.
Other Names:
  • OraTest Dye
  • Rinse Staining Procedure

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537199

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Zila Biotechnology
Investigators
Principal Investigator: Mark Chambers, DMD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Mark S. Chambers, MD / Professor, U.T. M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00537199     History of Changes
Other Study ID Numbers: 2005-1008
Study First Received: September 26, 2007
Results First Received: December 11, 2009
Last Updated: December 11, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Head And Neck
Oropharynx
Oral Cancer
OraTest
OraTest Dye
Rinse Staining Procedure
Visual Examination

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mouth Neoplasms
Oropharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 20, 2014