Photodynamic Therapy (PDT) With Temoporfin for Non-Resectable Non-Small-Cell Lung Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- Occurrence of serious adverse events [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).
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
Sponsors and Collaborators
- University of Arkansas
Investigators
- Principal Investigator: Mary E Meek, MD, University of Arkansas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 134367