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

Phase 2Active Not RecruitingNCT03085147

Memorial Sloan Kettering Cancer Center23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Oral Squamous Cell Carcinoma (OSCC)

Interventions

OlaparibDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, 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 Suffolk-Commack (Consent only)

Outcomes

Primary Outcomes

escalating levels of toxicity (CTCAE v 4.0)

toxicity data relevant to study interventions (CTCAE v 4.0)

Time frame: 1 year

Data from ClinicalTrials.gov

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