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

NCT01637376 | Withdrawn Phase 1

• 1 other identifier: 134367
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell-Lung

Keywords

Lung neoplasms; Non Small cell lung carcinoma; Non small cell lung cancer; Large cell carcinoma; squamous cell carcinoma; adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Occurrence of serious adverse events

  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).

  14 and 30 days post-therapy

Interventions

Temoporfin DRUG

A single dose of 0.04 mg per kilogram of body weight of Temoporfin will be administered by slow intravenous injection into a deep vein (such as the antecubital vein) in not less than 6 minutes and will not be flushed with sodium chloride or any other aqueous solution.

Also known as: Foscan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Carcinoma, Large Cell; Carcinoma, Squamous Cell; Adenocarcinoma

Interventions

temoporfin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Mary E Meek, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 11, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 15, 2014

Record last verified: 2014-01

Locations

US (1)