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Chemotherapy

Open-Label, Single Arm Study of PRV211 for Oral Squamous Cell Carcinoma

Phase 1 & 2

Recruiting

Research Sponsored by Privo Technologies

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tumor must be amenable to surgical resection.

Candidates for standard of care treatment consisting of surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-surgery or completion of adjuvant therapy

Awards & highlights

Study Summary

This trial is testing a new treatment called PRV211 that uses tiny particles to deliver chemotherapy directly to the tumor site during surgery. The goal is to kill any remaining cancer cells that couldn't be removed

Who is the study for?

Adults over 18 with a specific stage of oral cancer that can be surgically removed are eligible for this trial. They must have an ECOG Performance Status ≤2, indicating they're relatively able to carry out daily activities. Participants must agree to use two forms of birth control and not have any serious medical conditions that would affect their participation.Check my eligibility

What is being tested?

The study is testing PRV211, a nano-engineered device delivering chemotherapy directly to the site of tumor removal in oral cancer surgery. The aim is to target any remaining cancer cells locally without affecting the rest of the body. Up to 40 patients will be monitored for safety and effectiveness.See study design

What are the potential side effects?

Possible side effects aren't specified here, but generally, local chemotherapy may cause irritation or damage at the treatment site, pain, swelling, and could potentially lead to systemic issues like nausea or low blood counts if drugs enter circulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor can be removed with surgery.

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I am eligible for surgery as a standard treatment.

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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My cancer is in the early stages and located in my mouth or lip area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-surgery or completion of adjuvant therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post-surgery or completion of adjuvant therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-surgery or completion of adjuvant therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Endpoint

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531

29%

Nausea

19%

Leukopenia

14%

White blood cell count decreased

14%

Vomiting

14%

Thrombocytopenia

14%

Alanine aminotransferase increased

14%

Anaemia

14%

Neutropenia

10%

Neutrophil count decreased

10%

Platelet count decreased

10%

Aspartate aminotransferase increased

Dizziness

Back pain

Diarrhea

Musculoskeletal pain

100%

80%

60%

40%

20%

Study treatment Arm

Erlotinib-Chemotherapy

Chemotherapy-Erlotinib

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-Label, Single Arm Study of PRV211Experimental Treatment1 Intervention

PRV211 treatment application during standard of care tumor resection surgery. PRV211 system is comprised of two parts, a liquid permeation enhancer (PE) and cisplatin patch. The permeation is brushed onto the resected tumor bed and after 5 minutes the patch can be applied directly over the same area. Apply up to 2 layers of the PRV211 system to the tumor bed post-resection. The duration of the PRV211 treatment takes approximately 10-20 minutes and then the surgeon can continue as planned with the rest of the standard of care procedure. The proposed starting dose is 0.5 mg/cm2 of cisplatin on the tumor bed. This approach can be safe and effective in preventing locoregional recurrence after surgery and eliminating high-risk factors for local recurrence, such as dysplasia at the margins.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Privo TechnologiesLead Sponsor

1 Previous Clinical Trials

10 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,401 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"As per the information available on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The trial was initially posted for recruitment on October 16th, 2023 and has been updated most recently on January 16th, 2024."

Answered by AI

How large is the patient cohort involved in this ongoing medical study?

"Indeed, as indicated on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The study was initially posted on October 16th, 2023 and most recently updated on January 16th, 2024. Recruitment aims to enroll a total of 40 patients from one designated location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy Study of PRV211 in Subjects With Oral Squamous Cell Carcinoma

2023. "Safety and Efficacy Study of PRV211 in Subjects With Oral Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05893888.