From the blog

MPM PDT Phase II Trial

Published: July 16, 2014


Primary Outcome Measure:

  • Number of adverse events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

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 8 weeks 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 nonmelanomatous 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 8 weeks 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.
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