Safety and Efficacy Study of PRV111 in Subjects With Oral Squamous Cell Carcinoma

Completed · Phase 1/Phase 2

Conditions studied: Oral Squamous Cell Carcinoma

In brief

Up to 31 subjects diagnosed with oral squamous cell carcinoma received one application of a permeation enhancer 3 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of the 4 treatment visits. These 4 treatment visits were scheduled to occur during the 3 weeks prior to the standard of care tumor resection. Funding Source: FDA OOPD

Key facts

Study ID

NCT03502148

Run by

Privo Technologies

People needed

10

Starts

2018-06-19

Expected to finish

2020-05-06

Last updated by the study team

2022-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically confirmed T1 (<2 cm) or T2 (>2 cm but < or = 4 cm) squamous cell carcinoma (SCC) of the lip or oral cavity (anterior 2/3 of the tongue, floor of mouth, lower and upper gingiva, salivary gland, hard palate, and buccal mucosa).
• Tumor must be easily accessible, with no evidence of infection or active bleeding, encroaching major vessels or clinical evidence of neural invasion. Not previously irradiated.
• Tumors must be amenable to surgical resection no later than 21 days post Visit 1.
• Clinically or radiologically measurable tumor.
• ECOG Performance Status of < or =2.
• Adequate renal function as demonstrated by renal creatinine clearance.
• Adequate organ function as assessed by safety labs.
• Agree to use effective contraception for 30 days after the last dose of study drug.
• Absence of any serious medical conditions that would impair the subject's ability to participate.
• Willing and able to provide written informed consent.
• Able to return to the study site for treatment and follow-up visits as defined in the protocol.

You may not qualify if…

• Known distal metastasis of the SCC of the oral cavity.
• Systemic chemotherapy for the treatment of SCC of the head and neck less than 2 years prior to screening.
• Concurrent documented malignancy, with the exception of localized SCC of the skin.
• Exposure to any investigational agent within 3 months prior to screening.
• Known allergy or hypersensitivity to platinum-containing agents.
• Active, uncontrolled infection requiring systemic therapy.
• Known or suspected pregnancy, planned pregnancy or lactation.

Where it is running

• Advanced ENT and Allergy — Louisville, Kentucky, United States
• University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States
• Ben Taub Hospital — Houston, Texas, United States
• Memorial Hermann Hospital — Houston, Texas, United States
• The University of Texas Health Science Center School of Dentistry — Houston, Texas, United States

Full record on ClinicalTrials.gov

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