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Using MASL to Combat Oral Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04188665
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : April 27, 2022
Sponsor:
Collaborator:
Rutgers University
Information provided by (Responsible Party):
Rowan University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Head and Neck Drug: MASL Other: Placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 29, 2021
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MASL treated
Patients treated with lozenge containing MASL
 Drug: MASL
Patients treated with MASL lozenge
Other Name: Maackia amurensis seed lectin
Placebo Comparator: Placebo treated
Patients treated with lozenge without MASL
 Other: Placebo
Patients treated with placebo lozenge


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188665


Contacts
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Contact: GARY S GOLDBERG 8565666718 gary.goldberg@rowan.edu
Contact: Mahnaz Fatahzadeh 9739721956 fatahza@sdm.rutgers.edu

Locations
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United States, New Jersey
New Jersey Medical School Recruiting
Newark, New Jersey, United States, 07103
Contact: Mahnaz Fatazadeh, DMD, MSD    973-972-1956    fatahza@sdm.rutgers.edu   
Rutgers School for Dental Medicine Recruiting
Newark, New Jersey, United States, 07103
Contact: Mahnaz Fatahzadeh, DMD, MSD    973-972-1956    fatahza@sdm.rutgers.edu   
University Hospital Not yet recruiting
Newark, New Jersey, United States, 07103
Contact: Mahnaz Fatazadeh, DMD, MSD    973-971-1956    fatahza@sdm.rutgers.edu   
Rowan University Not yet recruiting
Stratford, New Jersey, United States, 08084
Contact: GARY GOLDBERG, PhD    856-566-6718    gary.goldberg@rowan.edu   
Sponsors and Collaborators
Rowan University
Rutgers University
More Information
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Responsible Party: Rowan University
ClinicalTrials.gov Identifier: NCT04188665    
Other Study ID Numbers: Pro2019000548
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rowan University:
maackia amurensis
podoplanin
pdpn
lectin
oral squamous cell carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Head and Neck Neoplasms
Neoplasms by Site
Lectins
Agglutinins
Immunologic Factors
Physiological Effects of Drugs
Coagulants