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

Phase 1
18 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell-Lung

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Trial Information

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

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

- 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

- 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

- 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Occurrence of serious adverse events

Outcome Description:

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).

Outcome Time Frame:

14 and 30 days post-therapy

Safety Issue:


Principal Investigator

Mary E Meek, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas


United States: Food and Drug Administration

Study ID:




Start Date:

July 2012

Completion Date:

September 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell-Lung
  • Lung neoplasms
  • Non Small cell lung carcinoma
  • Non small cell lung cancer
  • Large cell carcinoma
  • squamous cell carcinoma
  • adenocarcinoma
  • large cell carcinoma
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Arkansas for Medical Sciences Little Rock, Arkansas  72205