From the blog

Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy

Published: August 27, 2014


Primary Outcome Measure:

  • Number of patients who received the entire multi-modality regimen [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Incidence of grade 4 or greater toxicity in the post-operative period as graded by the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects) version 4.0 [ Time Frame: Up to 90 days post surgery ] [ Designated as safety issue: Yes ]
    All observed toxicities will be graded, tabled and summarized by frequencies and percentages.

Secondary Outcome Measures:

  • Overall survival [ Time Frame: Time from study entry (start of chemotherapy) to death due to any cause or last patient contact, assessed up to 2 years ] [ Designated as safety issue: No ]
    Estimated by the method of Kaplan and Meier. Overall survival will be estimated for all patients entered on trial, regardless of treatment received on-study or off-study.
  • Progression-free survival (PFS) [ Time Frame: Time from study entry to first documented progression (any type, intrapleural, distant, locoregional) or death due to any cause, assessed up to 2 years ] [ Designated as safety issue: No ]
    Estimated by the method of Kaplan and Meier. PFS will be estimated for all patients entered on trial, regardless of treatment received on-study or off-study.
  • Pleural progression-free survival (PPFS) [ Time Frame: Time from surgery/PDT to first documented intrapleural progression or death from any cause, assessed up to 2 years ] [ Designated as safety issue: No ]
    Estimated by the method of Kaplan and Meier. PPFS will be estimated for the subset of patients who receive PDT, in order to evaluate the impact of PDT on local control. Survival curves will be plotted. Median and 1-year estimates and confidence intervals will be calculated.
  • Porfimer sodium uptake defined as the ratio of the porfimer sodium concentration in tumor tissue to normal tissue (i.e. skin) using spectrofluorometric assay [ Time Frame: After surgery ] [ Designated as safety issue: No ]
    Porfimer sodium concentration in the tissue will be calculated based on the increase in fluorescence resulting from the addition of a known amount of porfimer sodium to each sample after its initial reading. Absolute concentrations of porfimer sodium will also be measured. Distribution of uptake will be summarized by mean, median, standard deviation, range, and histogram. The tumor: normal tissue ratio from direct and indirect measurements will be calculated. Spearman’s correlation will be employed to correlate and compare direct and indirect measurements.

Eligibility Criteria

Inclusion Criteria:
  • Histological diagnosis of NSCLC or MPM; pts must have clinical and/or pathological evidence of pleural spread or stage III/IV MPM
  • Pts with NSCLC who have received, are receiving or are planning to receive two to four cycles of standard frontline chemotherapy are eligible; choice of chemotherapy is at the discretion of the medical oncologist; concurrent chemoradiotherapy will not be permitted during the active study period; post-operative radiotherapy can be administered as clinically indicated
  • Assessment by the attending thoracic surgeon that the primary tumor is resectable in pts with NSCLC and pleural spread; tumor will be deemed resectable if there is no extension through fascia, no bony chest or vertebral body involvement, and no radiographic evidence of mediastinal involvement
  • Assessment by the attending thoracic surgeon that radical pleurectomy can be safely achieved in pts with malignant pleural mesothelioma
  • All studies required for evaluation will be performed within 8 weeks of Photofrin administration
  • Ps of all ethnic and gender groups will be included; protocol accrual will be reviewed annually to include a determination of minority and gender representation; if accrual demonstrates under-representation of any group with comparison to disease incidence in that group, then appropriate measures will be undertaken to attempt to increase participation of pts of that minority or gender group
  • Pts undergoing extrapleural pneumonectomy without PDT for MPM or stage IV (M1A) NSCLC (after American Joint Committee on Cancer [AJCC] staging change 2010) or stage IIIB (before staging change) with malignant pleural effusion treated at Ohio State University (OSU) from 2005-2012
  • Historical control data will be derived from patient medical records at the Ohio State University Medical Center (OSUMC)
Exclusion Criteria:
  • Pts who have grade III-IV elevations in liver transaminases (as defined by the Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 4.0) or a bilirubin in excess of 1.5 mg/dl
  • Pts who are medically unfit to tolerate surgery
  • Pts with known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) disease (routine testing is not needed if not clinical indicated)
  • Pregnant or lactating pts
  • Prior treatment for NSCLC except for pleurodesis and/or standard frontline chemotherapy
  • Pts who have received prior mantle or extensive mediastinal radiation
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