To hear about similar clinical trials, please enter your email below
Trial Title:
Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma
NCT ID:
NCT02153229
Condition:
Epitheliod Malignant Pleural Mesothelioma
Conditions: Official terms:
Mesothelioma
Mesothelioma, Malignant
Dihematoporphyrin Ether
Conditions: Keywords:
Histological diagnosis of MPM
epitheliod subtype
limited to the hemithorax
macroscopically complete resection of the tumor
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Photodynamic Therapy
Arm group label:
patients who undergo RP plus photofrin-based PDT
Other name:
PDT
Intervention type:
Procedure
Intervention name:
Radical Pleurectomy
Arm group label:
patients who undergo RP alone
Arm group label:
patients who undergo RP plus photofrin-based PDT
Other name:
RP
Intervention type:
Radiation
Intervention name:
Chemotherapy
Arm group label:
patients who undergo RP alone
Arm group label:
patients who undergo RP plus photofrin-based PDT
Intervention type:
Drug
Intervention name:
Photofrin 2.0 mg/kg
Description:
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
Arm group label:
patients who undergo RP plus photofrin-based PDT
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Rosewell Park
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly Dunn, MPH, CCRP
Phone:
716-845-1300
Phone ext:
6537
Email:
kelly.dunn@roswellpark.org
Contact backup:
Last name:
Elongia Farrell, BA, CCRC
Phone:
716-845-3114
Email:
elongia.farrell@roswellpark.org
Investigator:
Last name:
Sai Yendamuri, MD
Email:
Principal Investigator
Facility:
Name:
Abramson Cancer Center of the University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sally McNulty, RN
Phone:
215-662-7720
Email:
Sally.McNulty@uphs.upenn.edu
Contact backup:
Last name:
Keith Cengel, MD, PhD
Phone:
855-216-0098
Email:
PennCancerTrials@emergingmed.com
Investigator:
Last name:
Keith Cengel, MD, PhD
Email:
Principal Investigator
Start date:
May 2014
Completion date:
June 2025
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02153229
