Clinical Trials

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

 

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: May 2020

Allocation: Randomized, multicenter (Penn, RPCI)

Estimated Enrollment: 102 participants

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.

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: Nov 2021

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

Estimated Enrollment: 82 participants

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.

Principal Investigator: Dr. Hassan Arshad, MD, Roswell Park Cancer Institute

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

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