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Completed

NCT Number: NCT04188665

Using MASL to Combat Oral Cancer

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

New Jersey Medical School, Newark, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MASL

Drug

Patients treated with MASL lozenge

Other names: Maackia amurensis seed lectin

Placebo

Other

Patients treated with placebo lozenge

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Rowan University

Other

Collaborators

  • Rutgers University

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Dec 6, 2019
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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