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

  • STATUS
    Recruiting
  • End date
    Dec 20, 2022
  • participants needed
    102
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 20 June 2022

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.

Details
Condition Epitheliod Malignant Pleural Mesothelioma
Treatment Chemotherapy, photodynamic therapy, Radical Pleurectomy, Photofrin 2.0 mg/kg
Clinical Study IdentifierNCT02153229
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on20 June 2022

Eligibility

Yes No Not Sure

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note