Squamous Cell Carcinoma of Head and Neck
Conditions
Keywords
maackia amurensis, podoplanin, pdpn, lectin, oral squamous cell carcinoma
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).
Interventions
DRUGMASL
Patients treated with MASL lozenge
OTHERPlacebo
Patients treated with placebo lozenge
Sponsors
Rowan University
Rutgers University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-treatment OSCC Morphology and PDPN Expression | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-treatment OSCC Morphology and PDPN Expression | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGary S Goldberg
Rowan University
Participant flow
Recruitment details
18 subjects were consented and enrolled for consideration in this study. Of these, 8 subjects went on to the treatment phase of the study. Four of these 8 subjects were treated with MASL (experimental group) and four were treated with placebo (control group). The other 10 consented subjects were not considered for either MASL or placebo treatment, but their biological samples were still analyzed in the course of this study.
Pre-assignment details
18 subjects were consented and enrolled for consideration in this study. Of these, 8 subjects went on to the treatment phase of the study. Four of these 8 subjects were treated with MASL (experimental group) and four were treated with placebo (control group). The other 10 consented subjects were not considered for either MASL or placebo treatment, but their biological samples were still analyzed in the course of this study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 53.4 years |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 10 |
| other Total, other adverse events | 0 / 4 | 0 / 4 | 0 / 10 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 10 |
Outcome results
None listed