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Using MASL to Combat Oral Cancer

Primary Purpose

Squamous Cell Carcinoma of Head and Neck

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
MASL
Placebo
Sponsored by
Rowan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Head and Neck focused on measuring maackia amurensis, podoplanin, pdpn, lectin, oral squamous cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females of at least 18 years of age who are able to give consent.
  2. Smokers and non-smokers.
  3. Persons with white or red spots and/or lesions suspected or found to be oral cancer or precancer on the inner surface of the mouth.
  4. Oral lesions will be classified as OSCC or leukoplakia including, proliferative verrucous leukoplakia, conventional erythroplakia, suspect oral papillomas, or oral lichen planus. Only patients with such histologically confirmed diagnoses will be considered for inclusion.
  5. patients will be considered for inclusion at any stage of disease progression.
  6. Patients will be considered for inclusion if a subsequent biopsy or surgical resection are planned as part of their best care treatment.
  7. Patients will have an Eastern Cooperative Oncology Group performance status of 0 or 1.
  8. Patients will display normal organ function as evidenced by standard laboratory blood tests including liver enzymes and creatine.
  9. Patients will not present evidence of comorbidities including ongoing or active infection, unstable illness, or medical conditions.

Exclusion Criteria:

  1. Patients with cognitive impairments and cannot consent for themselves.
  2. Patients with language/hearing impairments.
  3. Use of a topical steroid product within the last 2 weeks.
  4. Pregnant women (to avoid any potential risk to the fetus) to be confirmed by standard blood or urine tests according to best care practice.
  5. Patients who are breastfeeding.
  6. Abstinence or use of adequate contraception will be required for women of childbearing potential and men of reproductive potential.

Sites / Locations

  • New Jersey Medical SchoolRecruiting
  • Rutgers School for Dental MedicineRecruiting
  • University Hospital
  • Rowan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MASL treated

Placebo treated

Arm Description

Patients treated with lozenge containing MASL

Patients treated with lozenge without MASL

Outcomes

Primary Outcome Measures

Pre-treatment OSCC morphology and PDPN expression
Measure morphology and podoplanin (PDPN) expression by immunohistochemistry of cells included in initial biopsies of oral lesions in comparison to normal oral squamous epithelial cells (OSCCs). We will select patients with lesions that express robust levels of PDPN and notable dysplasia for inclusion in the study.

Secondary Outcome Measures

Post-treatment OSCC morphology and PDPN expression
Evaluate and compare the PDPN expression and morphology of cells from included in resected oral lesions from patients treated with the experimental compound MASL or placebo. We will measure if MASL treatment decreases PDPN expression and normalizes morphology of OSCC cells on a defined scale of pathological examination by immunohistochemistry.

Full Information

First Posted
November 19, 2019
Last Updated
July 12, 2023
Sponsor
Rowan University
Collaborators
Rutgers University
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1. Study Identification

Unique Protocol Identification Number
NCT04188665
Brief Title
Using MASL to Combat Oral Cancer
Official Title
Using Maackia Amurensis Seed Lectin to Target the Podoplanin Receptor as a Functionally Relevant Biomarker to Inhibit the Growth of Oral Squamous Cell Carcinoma and Precancerous Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rowan University
Collaborators
Rutgers University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project will evaluate the expression of a receptor called podoplanin (PDPN) in cells from oral cancers and precancerous lesions. We will also determine how sensitive oral cancer cells are to a potential drug called Maackia amurensis seed lectin (MASL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Head and Neck
Keywords
maackia amurensis, podoplanin, pdpn, lectin, oral squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MASL treated
Arm Type
Experimental
Arm Description
Patients treated with lozenge containing MASL
Arm Title
Placebo treated
Arm Type
Placebo Comparator
Arm Description
Patients treated with lozenge without MASL
Intervention Type
Drug
Intervention Name(s)
MASL
Other Intervention Name(s)
Maackia amurensis seed lectin
Intervention Description
Patients treated with MASL lozenge
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients treated with placebo lozenge
Primary Outcome Measure Information:
Title
Pre-treatment OSCC morphology and PDPN expression
Description
Measure morphology and podoplanin (PDPN) expression by immunohistochemistry of cells included in initial biopsies of oral lesions in comparison to normal oral squamous epithelial cells (OSCCs). We will select patients with lesions that express robust levels of PDPN and notable dysplasia for inclusion in the study.
Time Frame
1 day to 4 weeks.
Secondary Outcome Measure Information:
Title
Post-treatment OSCC morphology and PDPN expression
Description
Evaluate and compare the PDPN expression and morphology of cells from included in resected oral lesions from patients treated with the experimental compound MASL or placebo. We will measure if MASL treatment decreases PDPN expression and normalizes morphology of OSCC cells on a defined scale of pathological examination by immunohistochemistry.
Time Frame
1 day to 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females of at least 18 years of age who are able to give consent. Smokers and non-smokers. Persons with white or red spots and/or lesions suspected or found to be oral cancer or precancer on the inner surface of the mouth. Oral lesions will be classified as OSCC or leukoplakia including, proliferative verrucous leukoplakia, conventional erythroplakia, suspect oral papillomas, or oral lichen planus. Only patients with such histologically confirmed diagnoses will be considered for inclusion. patients will be considered for inclusion at any stage of disease progression. Patients will be considered for inclusion if a subsequent biopsy or surgical resection are planned as part of their best care treatment. Patients will have an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients will display normal organ function as evidenced by standard laboratory blood tests including liver enzymes and creatine. Patients will not present evidence of comorbidities including ongoing or active infection, unstable illness, or medical conditions. Exclusion Criteria: Patients with cognitive impairments and cannot consent for themselves. Patients with language/hearing impairments. Use of a topical steroid product within the last 2 weeks. Pregnant women (to avoid any potential risk to the fetus) to be confirmed by standard blood or urine tests according to best care practice. Patients who are breastfeeding. Abstinence or use of adequate contraception will be required for women of childbearing potential and men of reproductive potential.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GARY S GOLDBERG
Phone
8565666718
Email
gary.goldberg@rowan.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mahnaz Fatahzadeh
Phone
9739721956
Email
fatahza@sdm.rutgers.edu
Facility Information:
Facility Name
New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahnaz Fatazadeh, DMD, MSD
Phone
973-972-1956
Email
fatahza@sdm.rutgers.edu
Facility Name
Rutgers School for Dental Medicine
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahnaz Fatahzadeh, DMD, MSD
Phone
973-972-1956
Email
fatahza@sdm.rutgers.edu
Facility Name
University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahnaz Fatazadeh, DMD, MSD
Phone
973-971-1956
Email
fatahza@sdm.rutgers.edu
Facility Name
Rowan University
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GARY GOLDBERG, PhD
Phone
856-566-6718
Email
gary.goldberg@rowan.edu

12. IPD Sharing Statement

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Using MASL to Combat Oral Cancer

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