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

NCT ID: NCT01637376

Last Updated: 2014-01-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Temoporfin

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.

Intervention Type: DRUG

Other Intervention Names

Foscan

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary E Meek, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

134367

Identifier Type: -

Identifier Source: org_study_id