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

This study has been withdrawn prior to enrollment.
(No participants were enrolled)
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01637376
First received: July 6, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell-Lung
Drug: Temoporfin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Photodynamic Therapy (PDT) With Temoporfin for Non-Resectable Non-Small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Occurrence of serious adverse events [ Time Frame: 14 and 30 days post-therapy ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 0
Study Start Date: July 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Foscan
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637376

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Mary E Meek, MD University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01637376     History of Changes
Other Study ID Numbers: 134367
Study First Received: July 6, 2012
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Arkansas:
Lung neoplasms
Non Small cell lung carcinoma
Non small cell lung cancer
Large cell carcinoma
squamous cell carcinoma
adenocarcinoma
large cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Temoporfin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on April 16, 2014