Spots Global Cancer Trial Database for Safety and Efficacy Study of PRV211 in Subjects With Oral Squamous Cell Carcinoma

Study Description

Brief Summary: PRV211 is a sterilized nano engineered delivery system intended for intraoperative chemotherapy treatment for all solid tumor surgeries immediately following surgical excision. The goal is to treat the tumor bed locally, eliminating any remaining micro metastases or close margins that are unable to be fully resected while avoiding system circulation. This study will enroll up to 40 subjects. In this study both safety and efficacy will be evaluated. All subjects will be monitored for possible DLTs.

Detailed Description: Methodology: This is a Phase 1/2, open-label, Safety and Efficacy, Tolerability, Anti-Tumor Effects, Systemic Exposure, and Device Technical Effects of PRV211 (Intraoperative Cisplatin System) in subjects with T2-T3 oral squamous cell carcinoma (SCC) amenable to surgery. Study Design: This study will enroll up to 40 subjects. An interim analysis will take place to evaluate safety and efficacy results and the addition of a second arm (see interim analysis section for further detail). In this study both safety and efficacy will be evaluated. All subjects will be monitored for possible DLTs. For the purpose of dose selection, tolerable dose is defined as a dose where fewer than 33% of subjects being evaluated within the safety population present with dose-limiting toxicities (DLTs). Effective dose is determined based on the evaluable population as described in the Statistical Methods section. The study is described below: Up to 15 subjects will be enrolled for stage 1 and undergo 1 PRV211 treatment application during standard of care tumor resection surgery. Each treatment will include permeation enhancer. If 5 or less respond, the dose can be escalated given safety requirements are met. A total of ten (10) PRV211 patches can be applied in this single application during tumor resection surgery. Definition of Response: A subject will be considered to have responded to the treatment if there is no incidence of locoregional recurrence at 3 months post-surgery and/or adjuvant therapy as indicated on positron emission tomography (PET) scan.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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