photodynamic therapy (pdt) with temoporfin for non-resectable non-small-cell lung cancer

Conditions: Carcinoma, Non-Small-Cell-Lung

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.

Keywords: lung neoplasms non small cell lung carcinoma non small cell lung cancer large cell carcinoma squamous cell carcinoma adenocarcinoma