---
title: Photodynamic Therapy (PDT) With Temoporfin for Non-Resectable Non-Small-Cell Lung Cancer
nct_id: NCT01637376
overall_status: WITHDRAWN
phase: PHASE1
sponsor: University of Arkansas
study_type: INTERVENTIONAL
primary_condition: Carcinoma, Non-Small-Cell-Lung
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01637376.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01637376"
ct_last_update_post_date: 2014-01-15
last_seen_at: "2026-05-12T06:49:51.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Photodynamic Therapy (PDT) With Temoporfin for Non-Resectable Non-Small-Cell Lung Cancer

**NCT ID:** [NCT01637376](https://clinicaltrials.gov/study/NCT01637376)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** No participants were enrolled
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** University of Arkansas
- **Conditions:** Carcinoma, Non-Small-Cell-Lung
- **Start Date:** 2012-07
- **Completion Date:** 2014-01
- **CT.gov Last Update:** 2014-01-15

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## 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.

## Primary Outcomes

- **Occurrence of serious adverse events** _(time frame: 14 and 30 days post-therapy)_ — 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).

## Locations (1)

- University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of arkansas for medical sciences|little rock|arkansas|united states` — added _(2026-05-12)_

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