Using MASL to Combat Oral Cancer

Squamous Cell Carcinoma of Head and Neck Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04188665
• Other study ID #: Pro2019000548
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 29, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Rowan University
• Contact: GARY S GOLDBERG
• Phone: 8565666718
• Email: gary.goldberg[@]rowan.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• MASL
Patients treated with MASL lozenge

Other:
• Placebo
Patients treated with placebo lozenge

Locations

Country	Name	City	State
United States	New Jersey Medical School	Newark	New Jersey
United States	Rutgers School for Dental Medicine	Newark	New Jersey
United States	University Hospital	Newark	New Jersey
United States	Rowan University	Stratford	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rowan University	Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day to 4 weeks.
Secondary	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.	1 day to 4 weeks.