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

NCT ID: NCT03502148

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2020-05-06

Brief Summary

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

Detailed Description

Up to 31 subjects diagnosed with oral squamous cell carcinoma received one application of a permeation enhancer and 3 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of 4 treatment visits. These 4 treatment visits were scheduled to occur during the 3 weeks prior to the standard of care tumor resection. After the surgery, subjects were followed for 6 months for disease recurrence.

Ten subjects were enrolled in the study. Up to 21 additional subjects could have been enrolled in Stage 2, if safety and efficacy endpoints were not met. The dose was not changed. All subjects were followed for 6 months post-surgery for disease recurrence.

During and at the conclusion of the treatment period, subjects were monitored for local and systemic safety, tumor response due to the treatment, and systemic drug exposure.

Conditions

Oral Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open-Label, Single Arm Study of PRV111

Subjects received 3 treatment applications of PRV111 (Cisplatin Transmucosal System) at each of the 4 planned visits within 3 weeks prior to their tumor surgery.

Group Type: EXPERIMENTAL

PRV111 (Cisplatin Transmucosal System)

Intervention Type: DRUG

Each treatment visit will include one application of a permeation enhancer and then 2, 3 or 5 PRV111 (Cisplatin Transmucosal System) applications depending on the Stage subject is enrolled in.

Interventions

PRV111 (Cisplatin Transmucosal System)

Each treatment visit will include one application of a permeation enhancer and then 2, 3 or 5 PRV111 (Cisplatin Transmucosal System) applications depending on the Stage subject is enrolled in.

Intervention Type: DRUG

Other Intervention Names

cisplatin

Eligibility Criteria

Inclusion Criteria

1. 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).

2. 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.

3. Tumors must be amenable to surgical resection no later than 21 days post Visit 1.

4. Clinically or radiologically measurable tumor.

5. ECOG Performance Status of < or =2.

6. Adequate renal function as demonstrated by renal creatinine clearance.

7. Adequate organ function as assessed by safety labs.

8. Agree to use effective contraception for 30 days after the last dose of study drug.

9. Absence of any serious medical conditions that would impair the subject's ability to participate.

10. Willing and able to provide written informed consent.

11. Able to return to the study site for treatment and follow-up visits as defined in the protocol.

Exclusion Criteria

1. Known distal metastasis of the SCC of the oral cavity.

2. Systemic chemotherapy for the treatment of SCC of the head and neck less than 2 years prior to screening.

3. Concurrent documented malignancy, with the exception of localized SCC of the skin.

4. Exposure to any investigational agent within 3 months prior to screening.

5. Known allergy or hypersensitivity to platinum-containing agents.

6. Active, uncontrolled infection requiring systemic therapy.

7. Known or suspected pregnancy, planned pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Privo Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manijeh Goldberg, PhD

Role: STUDY_DIRECTOR

CEO, Privo Technologies

Locations

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

Countries

United States

References

Goldberg M, Manzi A, Birdi A, Laporte B, Conway P, Cantin S, Mishra V, Singh A, Pearson AT, Goldberg ER, Goldberger S, Flaum B, Hasina R, London NR, Gallia GL, Bettegowda C, Young S, Sandulache V, Melville J, Shum J, O'Neill SE, Aydin E, Zhavoronkov A, Vidal A, Soto A, Alonso MJ, Rosenberg AJ, Lingen MW, D'Cruz A, Agrawal N, Izumchenko E. A nanoengineered topical transmucosal cisplatin delivery system induces anti-tumor response in animal models and patients with oral cancer. Nat Commun. 2022 Aug 17;13(1):4829. doi: 10.1038/s41467-022-31859-3.

Reference Type: DERIVED

PMID: 35977936 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

FD-R-006325

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

5R44CA192875-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CLN-001

Identifier Type: -

Identifier Source: org_study_id