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

Carcinoma, Non-Small-Cell-Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01637376
• Other study ID #: 134367
• Status: Withdrawn
• Phase: Phase 1
• First received: July 6, 2012
• Last updated: January 14, 2014
• Start date: July 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes