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MPM PDT Phase II Trial

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ClinicalTrials.gov Identifier: NCT02153229
Recruitment Status : Recruiting
First Posted : June 3, 2014
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Epitheliod Malignant Pleural Mesothelioma Radiation: Photodynamic Therapy Procedure: Radical Pleurectomy Radiation: Chemotherapy Drug: Photofrin 2.0 mg/kg Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2014
Estimated Primary Completion Date : May 2018


Arm Intervention/treatment
Experimental: patients who undergo RP plus photofrin-based PDT Radiation: Photodynamic Therapy
Other Name: PDT

Procedure: Radical Pleurectomy
Other Name: RP

Radiation: Chemotherapy
Drug: Photofrin 2.0 mg/kg
If randomized to the RP with PDT arm, subject will receive Photofrin 2.0 mg/kg as an intravenous infusion 24 hours (range 18-30 hours) prior to intra-operative light delivery (PDT) during radical pleurectectomy

Experimental: patients who undergo RP alone Procedure: Radical Pleurectomy
Other Name: RP

Radiation: Chemotherapy



Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: 4 years ]


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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:

  • Patients with a histologic diagnosis of MPM, epithelioid subtype, who in the opinion of the attending thoracic surgeon can receive a macroscopically complete resection of tumor.
  • Patients must have disease limited to the hemithorax.
  • Patients who have received prior surgery, gene therapy, or combination chemotherapy will be permitted if it has been at least 30 days since the last treatment.
  • Subjects treated with pemetrexed previously will be eligible only if 30 days have elapsed between the last dose of pemetrexed and the date of surgery.
  • ECOG performance status of 0-1.
  • Medical suitability for resection, including documented medical and cardiac clearance.
  • 18 years of age or older.
  • Patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks. Patients unwilling or unable due to cognitive impairment to sign informed consent are excluded from the study.

EXCLUSION CRITERIA

  • Patients with active invasive cancers, other than MPM, that require additional treatment, except non-melanomatous skin cancer, superficial bladder or cervical cancer, and early-stage prostate cancer
  • Pregnant or lactating patients.
  • Patients who have a history of HIV disease.
  • Patients who have a white count less than 2,500 per cubic mm or platelets less than 100,000/cubic mm.
  • Serum creatinine equal or greater than 2.5 mg/deciliter.
  • Patients who have severe liver disease including cirrhosis, Grade III-IV elevations in liver function studies, or bilirubin in excess of 1.5 mg/deciliter.
  • Patients with porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
  • Patients who have been treated with pemetrexed if the last dose of pemetrexed is < 30 days to the date of surgery.
  • Patients that have been treated with prior Mantle field radiation.
  • Patients with distant metastatic disease or otherwise not confined to the ipsilateral hemithorax.
  • Subjects who have received more than 2 doses of neo-adjuvant chemotherapy

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): NCT02153229


Contacts
Contact: Sally McNulty, RN 215-662-7720 Sally.Mcnulty@uphs.upenn.edu

Locations
United States, New York
Rosewell Park Recruiting
Buffalo, New York, United States, 14263
Contact: Kelly Dunn, MPH, CCRP    716-845-1300 ext 6537    kelly.dunn@roswellpark.org   
Contact: Elongia Farrell, BA, CCRC    716-845-3114    elongia.farrell@roswellpark.org   
Principal Investigator: Sai Yendamuri, MD         
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sally McNulty, RN    215-662-7720    Sally.McNulty@uphs.upenn.edu   
Contact: Keith Cengel, MD, PhD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Keith Cengel, MD, PhD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Keith Cengel, MD, PhD Abramson Cancer Center of the University of Pennsylvania

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02153229     History of Changes
Other Study ID Numbers: UPCC 14513
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: December 2016

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Histological diagnosis of MPM
epitheliod subtype
limited to the hemithorax
macroscopically complete resection of the tumor

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Dihematoporphyrin Ether
Hematoporphyrin Derivative
Trioxsalen
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents