Using MASL to Combat Oral Cancer

March 1, 2026 updated by: Rowan University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • University Hospital
      • Newark, New Jersey, United States, 07103
        • New Jersey Medical School
      • Newark, New Jersey, United States, 07103
        • Rutgers School for Dental Medicine
      • Stratford, New Jersey, United States, 08084
        • Rowan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MASL treated
Patients treated with lozenge containing MASL
Drug: MASL
Patients treated with MASL lozenge
Other Names:
  • Maackia amurensis seed lectin
Placebo Comparator: Placebo treated
Patients treated with lozenge without MASL
Other: Placebo
Patients treated with placebo lozenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-treatment OSCC Morphology and PDPN Expression
Time Frame: 1 day.
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 selected patients with lesions that express robust levels of PDPN and notable dysplasia for inclusion in the study. Intensity was graded on a scale of 1 to 5 with 5 having the most dysplastic morphology and highest PDPN expression.
1 day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-treatment OSCC Morphology and PDPN Expression
Time Frame: 1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rowan University

Collaborators

Rutgers University

Investigators

  • Principal Investigator: Gary S Goldberg, Rowan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

May 15, 2025

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (Actual)

December 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 1, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2019000548

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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