Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention

NCT01192204 | Completed Phase 1 Results

• 2 other identifiers: 2009C0086RC2CA148099
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multicenter placebo-controlled clinical trial to assess the effects of a topically applied gel on precancerous oral epithelial lesions. A total of 41 participants will be enrolled in this trial, and 22 of them will be enrolled at Ohio State. \[The remaining 19 participants will be enrolled at the University of North Carolina (9 participants) and the University of Louisville (8 participants)\]. At all three institutions, half of the participants will randomly be assigned to the 10% FBR gel (0.5 gm four times daily for 3 months), while half will enter the placebo control arm. All trial participants will have a pretreatment (including lesional and perilesional tissue) biopsy taken before and an excisional biopsy after 3 months of treatment. As pretreatment indices are compared to post treatment effects on each patient, patients serve as their own internal control. Pretreatment lesional biopsies are obtained to establish a pretreatment diagnosis and provide a pretreatment baseline for the experimental parameters.

Conditions

Squamous Cell Carcinoma of Mouth; Intraepithelial Neoplasia

Keywords

FBR, OSCC, chemoprevention

Outcome Measures

Primary Outcomes (1)

• Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment

  A hemisection of lesional tissue will be conducted before the 3 month treatment to establish a diagnosis and provide a pretreatment baseline for the experimental parameters. Anl excisional biopsy of the treatment site including any remaining residual lesional tissue (excision of oral dysplastic lesions is consistent with current standards of care) will be obtained after 3 months of treatment to provide a posttreatment diagnosis. The 0 to 8 histologic scale was:0=normal with or without hyperkeratosis BEST OUTCOME, 1=atypia, 2=mild dysplasia, 3=mild-moderate dysplasia, 4=moderate dysplasia,5=moderate-severe dysplasia,6=severe dysplasia, 7=carcinoma in situ, 8=invasive oral squamous cell carcinoma (WORST OUTCOME).

  Before and after the 3 month treatment.

Secondary Outcomes (2)

• Changes in Lesional Sizes

  pretreatment and posttreatment (3 months treatment duration)

• Treatment Changes in Loss of Heterozygosity Events

  Before and after the 3 month treatment duration

Study Arms (2)

10% FBR containing bioadhesive gel

ACTIVE COMPARATOR

Drug consisting of 10% FBR containing bioadhesive gel. Participants instructed to apply 0.5 gm of 10% FBR containing bioadhesive gel four times a day to lesional site

Drug: 10% FBR containing bioadhesive gel

Placebo Gel

PLACEBO COMPARATOR

Color/consistency matched placebo (no black raspberry) gel

Drug: placebo gel

Interventions

10% FBR containing bioadhesive gel DRUG

0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

Also known as: BRB gel

10% FBR containing bioadhesive gel

placebo gel DRUG

0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

Also known as: BRB devoid placebo gel

Placebo Gel

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages: 21 to 80
• Microscopically confirmed premalignant oral epithelial disease
• No previous history of cancer (with the exception of basal cell carcinoma of the skin)
• Tobacco free for at least six weeks prior to entrance in the trial and remain tobacco-free for the three month duration of the study
• Availability for necessary study follow-up evaluations (every 10 to 14 days during the trial)
• Capable of providing informed consent.

You may not qualify if:

• Previous history of cancer (with the exception of basal cell carcinoma of the skin)
• Current use of tobacco products or refusal to remain tobacco-free for the three month duration of the study
• Lack of microscopically confirmed premalignant oral epithelial changes
• Microscopic diagnosis of oral squamous cell carcinoma
• Previous history of radiation therapy on same side of the head and neck region
• History of allergy to any kind of berry
• Women who are determined to be pregnant or plan to be pregnant during the trial
• Women who are nursing.

Sponsors & Collaborators

• Ohio State University: lead
• University of Louisville: collaborator
• University of North Carolina, Chapel Hill: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of Louisville, School of Dentistry

Louisville, Kentucky, 40202, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

The Ohio State University, College of Dentistry

Columbus, Ohio, 43202, United States

Location

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  PMID: 24486592 RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma in Situ

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Limitations and Caveats

While we initially planned to include microvascular densities and COX-2 analyses, there were insufficient tissue samples to collect these data. Therefore as we do not have these data we can not report them.

Results Point of Contact

• Title: Susan R, Mallery DDS, PhD
• Organization: The Ohio State University

mallery.1@osu.edu

614 292-5892

Study Officials

• Susan R Mallery, DDS, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: August 31, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 14, 2015
• Results First Posted: August 14, 2015

Record last verified: 2013-11

Locations

US (3)