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

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ClinicalTrials.gov Identifier: NCT03085147
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oral Squamous Cell Carcinoma (OSCC) Drug: Olaparib Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: A Phase I/II Study of the Fluorescent PARP1 Binding Imaging Agent PARPi-FL in Patients With Oral Squamous Cell Carcinomas
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Olaparib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Fluorescent PARPi Binding Imaging Agent PARPi-FL
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.
 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.
Other Name: PARPi


Outcome Measures
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Primary Outcome Measures :
  1. escalating levels of toxicity (CTCAE v 4.0) [ Time Frame: 1 year ]
    toxicity data relevant to study interventions (CTCAE v 4.0)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085147


Contacts
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Contact: Heiko Schoder, MD 212-639-2079 schoderh@mskcc.org
Contact: Ravinder Greawl, MD 212-639-2872

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Heiko Schoder, MD    212-639-2079      
Contact: Ravinder Grewal, MD    212-639-2872      
Principal Investigator: Heiko Schoder, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Heiko Schoder, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03085147    
Other Study ID Numbers: 15-336
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Tongue
Mouth
Fluorescent PARP1 Binding Imaging Agent
PARPi-FL
15-336
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Head and Neck Neoplasms
Neoplasms by Site
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents