- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04188665
Using MASL to Combat Oral Cancer
July 12, 2023 updated by: Rowan University
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
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: GARY S GOLDBERG
- Phone Number: 8565666718
- Email: gary.goldberg@rowan.edu
Study Contact Backup
- Name: Mahnaz Fatahzadeh
- Phone Number: 9739721956
- Email: fatahza@sdm.rutgers.edu
Study Locations
-
-
New Jersey
-
Newark, New Jersey, United States, 07103
- Recruiting
- New Jersey Medical School
-
Contact:
- Mahnaz Fatazadeh, DMD, MSD
- Phone Number: 973-972-1956
- Email: fatahza@sdm.rutgers.edu
-
Newark, New Jersey, United States, 07103
- Recruiting
- Rutgers School for Dental Medicine
-
Contact:
- Mahnaz Fatahzadeh, DMD, MSD
- Phone Number: 973-972-1956
- Email: fatahza@sdm.rutgers.edu
-
Newark, New Jersey, United States, 07103
- Not yet recruiting
- University Hospital
-
Contact:
- Mahnaz Fatazadeh, DMD, MSD
- Phone Number: 973-971-1956
- Email: fatahza@sdm.rutgers.edu
-
Stratford, New Jersey, United States, 08084
- Not yet recruiting
- Rowan University
-
Contact:
- GARY GOLDBERG, PhD
- Phone Number: 856-566-6718
- Email: gary.goldberg@rowan.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Males and females of at least 18 years of age who are able to give consent.
- Smokers and non-smokers.
- 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.
- 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.
- patients will be considered for inclusion at any stage of disease progression.
- Patients will be considered for inclusion if a subsequent biopsy or surgical resection are planned as part of their best care treatment.
- Patients will have an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Patients will display normal organ function as evidenced by standard laboratory blood tests including liver enzymes and creatine.
- Patients will not present evidence of comorbidities including ongoing or active infection, unstable illness, or medical conditions.
Exclusion Criteria:
- Patients with cognitive impairments and cannot consent for themselves.
- Patients with language/hearing impairments.
- Use of a topical steroid product within the last 2 weeks.
- Pregnant women (to avoid any potential risk to the fetus) to be confirmed by standard blood or urine tests according to best care practice.
- Patients who are breastfeeding.
- Abstinence or use of adequate contraception will be required for women of childbearing potential and men of reproductive potential.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MASL treated
Patients treated with lozenge containing MASL
|
Patients treated with MASL lozenge
Other Names:
|
Placebo Comparator: Placebo treated
Patients treated with lozenge without MASL
|
Patients treated with placebo lozenge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-treatment OSCC morphology and PDPN expression
Time Frame: 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.
|
1 day to 4 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-treatment OSCC morphology and PDPN expression
Time Frame: 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.
|
1 day to 4 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2021
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
November 19, 2019
First Submitted That Met QC Criteria
December 3, 2019
First Posted (Actual)
December 6, 2019
Study Record Updates
Last Update Posted (Actual)
July 13, 2023
Last Update Submitted That Met QC Criteria
July 12, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2019000548
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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