Clinical trial NCT01637376: Photodynamic Therapy (PDT) With Temoporfin for Non-Resectable Non-Small-Cell Lung Cancer
Official title: Photodynamic Therapy (PDT) With Temoporfin for Non-Resectable Non-Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell-Lung
Keywords: Lung neoplasms
Non Small cell lung carcinoma
Non small cell lung cancer
Large cell carcinoma
squamous cell carcinoma
adenocarcinoma
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Occurrence of serious adverse events
timeFrame: 14 and 30 days post-therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Mary E Meek, MD
role: PRINCIPAL_INVESTIGATOR
References: