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Clinical Trials

On-going clinical trials by our academic collaborators funded by National Cancer Institute (NCI)

Roswell

Endobronchial Ultrasound (EBUS) Guided Interstitial Photodynamic Therapy (I-PDT) in Treating Patients With Locally Advanced Lung Cancer (LALC)

 

Sponsor:  Roswell Park Cancer Institute

ClinicalTrials.gov Identifier:  NCT03735095

Collaborators: National Cancer Institute (NCI) (Funding Source), Pinnacle Biologics, Inc., Simphotek Inc.

Start date: Feb 2020

Estimated Primary Completion date: Feb 2024

Allocation: RPCI

Estimated Enrollment: 36 participants

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Summary: 

  • This Phase I/Ila studies the side effects of EBUS guided I-PDT work in treating patients with lung cancer that has spread to nearby tissues or lymph nodes.

  • Phase (I): To evaluate the safety and potential efficacy of EBUS with transbronchial needle guided I-PDT in patients with LALC in the central airway, using Photofrin®

  • Phase (II): To assess the tumor response to treatment; to observe changes in well being.

  • Phase (II): (Secondary) To evaluate local progression-free survival (PFS) 

  • Phase (II): (Secondary) To compare the treatment planning in Dosie™ with the plan generated in COMSOL Multiphysics®.

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Principal Investigator: Dr. Nathaniel Ivanick, MD, Roswell Park Cancer Institute

Penn

A Randomized Phase 2 Trial of Radical Pleurectomy and Post-Operative Chemotherapy With or Without Intraoperative Porfimer Sodium -Mediated Photodynamic Therapy for Patients With Epitheliod Malignant Pleural Mesothelioma

 

Sponsor:  Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:  NCT02153229

Collaborator: National Cancer Institute (NCI) (Funding Source)

Start date: May 2014

Estimated Primary Completion date: Jun 2023

Allocation: Randomized, multicenter (Penn, RPCI)

Estimated Enrollment: 102 participants

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Summary: 

A randomized Phase II trial to test whether the addition of intraoperative Photofrin-mediated photodynamic therapy to radical pleurectomy and post-operative chemo.  improves OS in the treatment of patients with epithelioid MPM. Subjects assigned to the PDT arm will be given the photosensitizer prior to surgery. All subjects will receive maximal surgical debulking. Subjects in the PDT arm will receive intraoperative treatment using real-time, isotropic light dosimetry.

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Principal Investigator: Keith Cengel, MD, PhD (Simphotek’s Scientific Advisory Board Member) Abramson Cancer Center of the University of Pennsylvania

Roswell

Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer

 

Sponsor:  Roswell Park Cancer Institute

ClinicalTrials.gov Identifier:  NCT03727061

Collaborator: National Cancer Institute (NCI) (Funding Source)

Start date: Jan 2019

Estimated Primary Completion date: Aug 2023

Allocation: Randomized, multicenter (Penn, RPCI, Johns Hopkins, Univ. of Arkansas)

Estimated Enrollment: 82 participants

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Summary: 

  • Phase (I): To determine the incidence of adverse events per National Cancer Institute (NCI Common Terminology Criteria for Adverse Events (CTCAE)

  • Phase (II): To compare progression-free survival (PFS) and overall survival (OS) between adjuvant porfimer sodium      mediated I-PDT with SoC therapy and SoC alone, in patients with locally advanced or recurrent HNC

  • Phase (II): To compare changes in quality of life (QoL) between adjuvant porfimer sodium mediated I-PDT with SoC therapy and SoC alone, in patients with locally advanced or recurrent HNC.

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Principal Investigator: Dr. Kimberly Wooten, MD, Roswell Park Cancer Institute

Note: Roswell=Roswell Park Cancer Institute, Penn=Hospital of the Univ. of Pennsylvania

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