Using MASL to Combat Oral Cancer

Rowan University

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Squamous Cell Carcinoma of Head and Neck

Treatments: Drug: MASL; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04188665

Pro2019000548

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

MASL treated

Experimental group

Description:

Patients treated with lozenge containing MASL

Treatment:

Drug: MASL

Placebo treated

Placebo Comparator group

Description:

Patients treated with lozenge without MASL

Treatment:

Other: Placebo