Clinical Trial 19226

Cancer Type:
Interventions:Porfimer Sodium (Photofrin)

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Eric Toloza

Overview

Study Title

A Multicenter, Prospective, Open-Label, Non-Randomized Single-Arm Clinical Study Of The Safety And Tissue Response To Photodynamic Therapy Using Porfimer Sodium For Injection As Treatment For Solid Tumor In Peripheral Lung Prior To Surgical Resection

Summary

This research study is being conducted to assess the safety of photodynamic therapy (PDT) in participants with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites in USA. Participation will last 4 months.

Objective

The study aims to assess: The safety of PDT in subjects with solid tumors in the peripheral lung prior to surgery to remove the tumor. The effect of PDT on lung tumor and healthy tissue near the lung tumor when used prior to surgery to remove the tumor.

Inclusion Criteria

  • Male or female aged 18-79
  • Diagnosed with primary or metastatic tumor less than 5 cm located in peripheral lung
  • Candidate for surgical resection
  • Candidate for bronchoscopy

  • Exclusion Criteria

  • Diagnostic of small cell lung cancer or carcinoid tumors
  • Primary or metastatic lung tumor located in central lung or near vertebral body
  • Tumor invades a major blood vessel
  • Presence of concurrent non-solid malignancy
  • Tumor previously treated with radiation therapy
  • Chemotherapy in the last four weeks
  • Tumor treated with PDT within the last 3 months
  • Abnormal blood results