A Dye for the Detection of Cancer of the Tongue and Mouth

Oral Squamous Cell Carcinoma (OSCC) Clinical Trial

Official title:

A Phase I/II Study of the Fluorescent PARP1 Binding Imaging Agent PARPi-FL in Patients With Oral Squamous Cell Carcinomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03085147
• Other study ID #: 15-336
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 15, 2017
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Heiko Schoder, MD
• Phone: 212-639-2079
• Email: schoderh[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test if an investigational dye, called PARPi-FL, can be used to detect this type of cancer. This will be the first time that PARPi-FL is being tried in people. First, the investigators will test the safety of PARPi-FL at different doses to find out what effects, if any, it has on people. The investigators will also see which amount of PARPi-FL is best suited to detect cancers of the mouth and tongue.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is = 18 years old

• Histologically or cytologically proven squamous cell carcinoma of the oral cavity or pharynx (OSCC)

• Scheduled to undergo surgery at MSK

• Any tumor stage, any N, M0

• ECOG performance status 0 or 1

Exclusion Criteria:

• Any surgical therapy in the area of the oral cavity or pharynx within the last 2 weeks

• Prior or ongoing treatment with a PARP1 inhibitor

• Known hypersensitivity to Olaparib

• Known hypersensitivity to PEG Eligibility criteria will be assessed by an experienced oral surgeon, typically the Co-PI of the study.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oral Squamous Cell Carcinoma (OSCC)
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Olaparib
For PARRi-FL, imaging patients will first gargle a solution of PARRi-FL for 1 min, then spit out this solution and gargle with a cleaning solution (the solvent used for PARRi-FL) for 1 min. Then fluorescence imaging of the oral cavity and pharynx will be performed with an endoscope. The intensity and extent of the fluorescence signal will be recorded by one of the investigators for the tumor and adjacent normal mucosa.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent Only)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk-Commack (Consent only)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent Only)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent only)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent only)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	escalating levels of toxicity (CTCAE v 4.0)	toxicity data relevant to study interventions (CTCAE v 4.0)	1 year

External Links

•   Memorial Sloan Kettering Cancer Center