Clinical trial NCT04188665: Using MASL to Combat Oral Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: maackia amurensis
podoplanin
pdpn
lectin
oral squamous cell carcinoma
Lead sponsor: Rowan University
Sponsor class: OTHER
Collaborators: name: Rutgers University
First posted: 2019-12-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Pre-treatment OSCC morphology and PDPN expression
timeFrame: 1 day to 4 weeks.
Secondary outcomes:
measure: Post-treatment OSCC morphology and PDPN expression
timeFrame: 1 day to 4 weeks.
Other outcomes:
Locations:
city: Newark
country: United States
facility: New Jersey Medical School
state: New Jersey
city: Newark
country: United States
facility: Rutgers School for Dental Medicine
state: New Jersey
city: Newark
country: United States
facility: University Hospital
state: New Jersey
city: Stratford
country: United States
facility: Rowan University
state: New Jersey
Study officials:
References: