Photodynamic Therapy (PDT) With Temoporfin for Non-Resectable Non-Small-Cell Lung Cancer

Phase 1

Withdrawn

• Conditions: Carcinoma, Non-Small-Cell-Lung

• Registration Number: NCT01637376
• Lead Sponsor: University of Arkansas

Brief Summary

The purpose of this study is to evaluate the safety of I-PDT with Temoporfin for patients with Non-Resectable Non-Small-Cell Lung Cancer (NR-NSCLC). Several clinical studies suggested that photodynamic therapy (PDT) may be an effective treatment for patients with NR-NSCLC. PDT is a therapy where an external light source, such as laser, is used to activate a light-sensitive medicine to produce byproducts that can destroy cancer cells. In this study the investigators will use an experimental light sensitive medicine, Temoporfin, to perform interstitial PDT (I-PDT). In I-PDT, laser fibers are inserted into the tumor to activate the light-sensitive medicine.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Eighteen years of age and older, male or female, of all races and ethnicities.

• Histologically confirmed non-small-cell lung cancer (NSCLC).

• Not a candidate for curative surgery.

• Not a candidate for curative concurrent chemoradiation therapy.

• Not a candidate or does not wish to receive curative radiation therapy.

• Not a candidate or does not wish to receive radiofrequency or microwave thermal ablation.

• Have an Eastern Cooperative Oncology Group (ECOG) performance status < 2.

• The tumor is observable in CT with contrast.

• The tumor is accessible for unrestricted illumination of interstitial photodynamic therapy (I-PDT).

• Deemed likely to survive for at least 3 months.

• Patient is able and willing to provide written informed consent to participate in the study.

• If the subject is a female of childbearing potential, the subject is willing to take a pregnancy test and practice strict birth control (estrogen-containing oral contraceptives or an intrauterine device) throughout the study and for 3 months after Temoporfin administration. Women who have had a hysterectomy are exempt from these requirements.

• Subject is willing to remain in a controlled light exposure environment for a time period of at least 15 days.

• History of laboratory tests that meet the following criteria

• Hematocrit >= 33%, hemoglobin >= 11 g/dl

  • Platelet count > 70,000 per microliter
  • White blood count > 3,000 per microliter or ANC > 1500 per microliter
  • Creatinine: 0.8 to 1.4 mg/dL
  • Serum chloride: 101 to 111 mmol/L
  • Serum potassium: 3.7 to 5.2 mEq/L
  • Serum sodium: 136 to 144 mEq/L
  • Liver function test: albumin, bilirubin (direct/conjugated), ALT (alanine transaminase), AST (aspartate transaminade), GGT (gamma glutamyl transferase), ALP (alkaline phosphatase) within normal limits
  • BUN: 7 to 20 mg/dL

Exclusion Criteria

• The tumor invades a major blood vessel.
• The tumor is not clearly shown on the CT image.
• The tumor size is larger than 5 cm when measured in a contrasted CT image according to RECIST v1.1.
• The location and extension of the tumor precludes an effective I-PDT.
• Patient with porphyria or other diseases exacerbated by light.
• Patient with hypersensitivity to Temoporfin or to any of its excipients.
• Patient with known allergies/hypersensitivity to porphyrins.
• Patient with a planned surgical procedure within the next 30 days.
• Patient with a coexisting ophthalmic disease likely to require slit-lamp examination within the next 30 days.
• Patient with existing therapy with a photosensitizing agent (Temoporfin, porphyrin or derivatives of porphyrin).
• Patient has received prior PDT to the proposed treatment site within the prior 3 months.
• Patient with known sensitivity to the CT contrast agent (Omnipaque), which would preclude the use of the CT contrast agent.
• History of poor renal function as demonstrated by serum creatinine and estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73m2, which would preclude the using of the CT contrast agent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Occurrence of serious adverse events	14 and 30 days post-therapy	The specific aim of this pilot study is to evaluate the safety of CT-guided I-PDT with Temoporfin on patients with NR-NSCLC. Patient safety will be the primary endpoint. The safety of the intervention will be assessed at 14 and 30 days post-therapy. The primary outcome will be occurrence of Serious Adverse Events (SAE).

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States