Using MASL to Combat Oral Cancer

Early Phase 1

Active, not recruiting

• Conditions: Squamous Cell Carcinoma of Head and Neck
• Interventions: Drug: MASL; Other: Placebo

• Registration Number: NCT04188665
• Lead Sponsor: Rowan University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-06
• Study Start: 2021-01-29
• Primary Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MASL treated	MASL	Patients treated with lozenge containing MASL
Placebo treated	Placebo	Patients treated with lozenge without MASL

Primary Outcome Measures

Name	Time	Method
Pre-treatment OSCC morphology and PDPN expression	1 day to 4 weeks.	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

Name	Time	Method
Post-treatment OSCC morphology and PDPN expression	1 day to 4 weeks.	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.

Trial Locations

Locations (4)

New Jersey Medical School; 🇺🇸 Newark, New Jersey, United States

Rutgers School for Dental Medicine; 🇺🇸 Newark, New Jersey, United States

Rowan University; 🇺🇸 Stratford, New Jersey, United States

University Hospital; 🇺🇸 Newark, New Jersey, United States