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

Primary Purpose

Oral Squamous Cell Carcinoma (OSCC)

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Olaparib

About this trial

This is an interventional diagnostic trial for Oral Squamous Cell Carcinoma (OSCC) focused on measuring Tongue, Mouth, Fluorescent PARP1 Binding Imaging Agent, PARPi-FL, 15-336

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Memorial Sloan Kettering Basking Ridge (Consent Only)Recruiting
Memorial Sloan Kettering Monmouth (Consent only)Recruiting
Memorial Sloan Kettering Bergen (Consent only)Recruiting
Memorial Sloan Kettering Suffolk-Commack (Consent only)Recruiting
Memorial Sloan Kettering Westchester (Consent Only)Recruiting
Memorial Sloan Kettering Cancer CenterRecruiting
Memorial Sloan Kettering Nassau (Consent only)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluorescent PARPi Binding Imaging Agent PARPi-FL

Arm Description

In the phase I of the study, increasing concentrations of PARPi-FL will be used in up to 12 patients with OSCC to determine concentration that results in the highest contrast between tumor and normal mucosa. Dose escalation will be performed in groups of three patients until image contrast decreases, side effects are noted or the concentration of PARPi-FL exceeds 1μM. Imaging will be performed in the Department of Surgery during a presurgical visit including clinical examination of the oral cavity. In the phase II part of the study the concentration of PARPi-FL determined in phase I will be used to image 18 patients with OSCC on the day of surgery. Imaging findings will be correlated with histopathologic findings in the surgically resected specimens.

Outcomes

Primary Outcome Measures

escalating levels of toxicity (CTCAE v 4.0)

toxicity data relevant to study interventions (CTCAE v 4.0)

Secondary Outcome Measures

Full Information

NCT ID

NCT03085147

First Posted

March 15, 2017

Last Updated

May 31, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03085147

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 15, 2017 (Actual)

Primary Completion Date

July 2026 (Anticipated)

Study Completion Date

July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Squamous Cell Carcinoma (OSCC)

Keywords

Tongue, Mouth, Fluorescent PARP1 Binding Imaging Agent, PARPi-FL, 15-336

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

This is an open label, investigator initiated single arm phase I/II study. The concentration for imaging OSCC is defined in Phase I. Phase II will then use this concentration to obtain preliminary data on the sensivity of PARPi-FL to detect and delinate OSCC.

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fluorescent PARPi Binding Imaging Agent PARPi-FL

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Olaparib

Other Intervention Name(s)

PARPi

Intervention Description

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.

Primary Outcome Measure Information:

Title

escalating levels of toxicity (CTCAE v 4.0)

Description

toxicity data relevant to study interventions (CTCAE v 4.0)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Heiko Schoder, MD

Phone

212-639-2079

schoderh@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Ravinder Greawl, MD

Phone

212-639-2872

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heiko Schoder, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Basking Ridge (Consent Only)

City

Basking Ridge

State/Province

New Jersey

ZIP/Postal Code

07920

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heiko Schoder, MD

Phone

212-639-2079

Facility Name

Memorial Sloan Kettering Monmouth (Consent only)

City

Middletown

State/Province

New Jersey

ZIP/Postal Code

07748

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heiko Schoder, MD

Phone

212-639-2079

Facility Name

Memorial Sloan Kettering Bergen (Consent only)

City

Montvale

State/Province

New Jersey

ZIP/Postal Code

07645

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heiko Schoder, MD

Phone

212-639-2079

Facility Name

Memorial Sloan Kettering Suffolk-Commack (Consent only)

City

Commack

State/Province

New York

ZIP/Postal Code

11725

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heiko Schoder, MD

Phone

212-639-2079

Facility Name

Memorial Sloan Kettering Westchester (Consent Only)

City

Harrison

State/Province

New York

ZIP/Postal Code

10604

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heiko Schoder, MD

Phone

212-639-2079

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heiko Schoder, MD

Phone

212-639-2079

First Name & Middle Initial & Last Name & Degree

Ravinder Grewal, MD

Phone

212-639-2872

First Name & Middle Initial & Last Name & Degree

Heiko Schoder, MD

Facility Name

Memorial Sloan Kettering Nassau (Consent only)

City

Rockville Centre

State/Province

New York

ZIP/Postal Code

11553

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heiko Schoder, MD

Phone

212-639-2079

12. IPD Sharing Statement

Citations:

PubMed Identifier

33954826

Citation

Demetrio de Souza Franca P, Kossatz S, Brand C, Karassawa Zanoni D, Roberts S, Guru N, Adilbay D, Mauguen A, Valero Mayor C, Weber WA, Schoder H, Ghossein RA, Ganly I, Patel SG, Reiner T. A phase I study of a PARP1-targeted topical fluorophore for the detection of oral cancer. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3618-3630. doi: 10.1007/s00259-021-05372-6. Epub 2021 May 5.

Results Reference

derived

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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