- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01637376
Photodynamic Therapy (PDT) With Temoporfin for Non-Resectable Non-Small-Cell Lung Cancer
January 14, 2014 updated by: University of Arkansas
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
14 and 30 days post-therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary E Meek, MD, University of Arkansas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (ACTUAL)
January 1, 2014
Study Completion (ACTUAL)
January 1, 2014
Study Registration Dates
First Submitted
July 6, 2012
First Submitted That Met QC Criteria
July 10, 2012
First Posted (ESTIMATE)
July 11, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
January 15, 2014
Last Update Submitted That Met QC Criteria
January 14, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Antineoplastic Agents
- Photosensitizing Agents
- Dermatologic Agents
- Temoporfin
Other Study ID Numbers
- 134367
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Non-Small-Cell-Lung
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma | Non-Squamous Non-Small...United States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Recurrent Lung Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IA...United States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage I Lung Non-Small Cell Cancer AJCC v7 | Stage...United States
-
National Cancer Institute (NCI)Active, not recruitingLung Non-Squamous Non-Small Cell Carcinoma | Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7United States, Puerto Rico
-
National Cancer Institute (NCI)Active, not recruitingStage IIIA Lung Non-Small Cell Cancer AJCC v7 | Advanced Lung Non-Squamous Non-Small Cell Carcinoma | Metastatic Lung Non-Squamous Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IV Lung Non-Small Cell Cancer AJCC v7 | Stage III Lung Non-Small Cell Cancer AJCC...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Society of Thoracic RadiologyActive, not recruitingStage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
Clinical Trials on Temoporfin
-
Quintiles, Inc.Unknown
-
Roswell Park Cancer InstituteNational Institutes of Health (NIH); Biolitec Pharma Ltd.WithdrawnTongue Cancer | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous Cell Carcinoma of the Oropharynx | Recurrent Verrucous Carcinoma of the Oral Cavity | Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity | Stage I Squamous Cell Carcinoma of the Oropharynx and other conditions
-
Chinese University of Hong KongCompletedCholangiocarcinoma | Klatskin Tumor | TumorHong Kong
-
University of SalzburgBiolitec Pharma Ltd.UnknownNon-curative Resectable Bile Duct CarcinomaAustria, Germany
-
University of ArkansasErasmus Medical Center; The Netherlands Cancer Institute; Biolitec Pharma Ltd.TerminatedSquamous Cell Carcinoma of the Head and NeckUnited States
-
Roswell Park Cancer InstituteCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung CarcinomaUnited States