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Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma (MPM-PDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02153229
Recruitment Status : Suspended (Covid-19)
First Posted : June 3, 2014
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE May 28, 2014
First Posted Date  ICMJE June 3, 2014
Last Update Posted Date April 24, 2020
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
Number of adverse events [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epitheliod Malignant Pleural Mesothelioma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: patients who undergo RP plus photofrin-based PDT
    Interventions:
    • Radiation: Photodynamic Therapy
    • Procedure: Radical Pleurectomy
    • Radiation: Chemotherapy
    • Drug: Photofrin 2.0 mg/kg
  • Experimental: patients who undergo RP alone
    Interventions:
    • Procedure: Radical Pleurectomy
    • Radiation: Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: June 26, 2014)
102
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2014)
20
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02153229
Other Study ID Numbers  ICMJE UPCC 14513
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abramson Cancer Center of the University of Pennsylvania
Study Sponsor  ICMJE Abramson Cancer Center of the University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Keith Cengel, MD, PhD Abramson Cancer Center of the University of Pennsylvania
PRS Account Abramson Cancer Center of the University of Pennsylvania
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP