AzTrials
AzTrials

Carcinoma, Non-Small-Cell-LungPhase 1NCT01637376

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

A Phase 1 study testing Temoporfin in people with Carcinoma, Non-Small-Cell-Lung, run by University of Arkansas at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell-Lung
What is being tested?
Temoporfin
Type of treatment
Injection or infusion
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2012to Jan 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 23Show fewer
  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

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.

Being tested
Temoporfin
Keywords
Lung neoplasms, Non Small cell lung carcinoma, Non small cell lung cancer, Large cell carcinoma, squamous cell carcinoma, adenocarcinoma
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Carcinoma, Large Cell, Carcinoma, Squamous Cell, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TemoporfinDrug

    Also called Foscan

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 14 and 30 days post-therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJan 2014
  4. Study completionJan 2014

Why it stopped: No participants were enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01637376
Sponsor's protocol ID
134367
Status last verified
Jan 2014
First submitted
6 Jul 2012
Last updated
15 Jan 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Temoporfin in people with Carcinoma, Non-Small-Cell-Lung, run by University of Arkansas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of serious adverse events (time frame: 14 and 30 days post-therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01637376.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in