non small cell lung cancer (NSCLC) MedDRA version: 17.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Fotolon
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: CHLORIN E6
CAS Number: 19660-77-6
Current Sponsor code: Ce6Na
Other descriptive name: CHLORIN E6
Conc
Sponsors
Apocare Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged ? 18 years. 2. Patients with histologic confirmed NSCLC with completely or partially obstructing endobronchial lesions with or without extrabronchial tumor requiring therapy and amenable to bronchoscopic intervention. 3. Patients with tumors, which were already treated with a first line therapy (e.g. chemotherapy), having recurrent, therapy resistant or inoperable tumors. 4. Patients presenting with pulmonary symptoms attributable to the endobronchial lesion (e.g. dyspnea, cough, hemoptysis, retention pneumonia). 5. Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status ?2 at study entry. 6. Patients with an anticipated life expectancy of at least 3 months . 7. Patients with an adequate hematologic capacity, defined by - WBC ? 3.5 x 109 / l - Platelets ? 150 x 109 / l - Hemoglobin ? 10 g / dl. 8. Patients with adequate liver function, defined by - serum bilirubin ? 2.0 mg / dl - SGOT, SGPT, GGT ? 3 times ULN. 9. Patients with adequate renal function, defined by - serum creatinine ? 1.5 mg / dl or - creatinine clearance ? 60 ml/min. 10. Prothrombin time ? 1.5 x ULN 11. Complete recovery from relevant toxicities of any prior treatment. 12. Effective contraception for women of childbearing potential (=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breast feeding. 2. Women of child-bearing potential not under adequate contraceptive protection (>1% failure rate) and men not executing contraceptive protection. 3. Patients with clinically relevant infection. 4. Past or current history of another malignant disease which has not been curatively treated and has been without evidence of disease for less than 3 years, except non-melanoma skin cancer and in situ carcinoma of the cervix. 5. Porphyria or hypersensitivity against porphyrins or other diseases known to be exacerbated by light. 6. Hypersensitivity to Fotolon® or to any of the excipients of the study medication. 7. Tumors with known or suspected erosion of major blood vessel in or adjacent to the illumination area. 8. Patients with thoracic radiotherapy within the last 4 weeks prior to inclusion in the study. 9. Patients with chemotherapy (including radiochemotherapy) within the last 4 weeks prior to inclusion in the study (Mitomycin C or Nitrosureas: 6 weeks). 10. Patients who have had thoracic surgery within the last 4 weeks. 11. Patients who had other surgery within the last 2 weeks, unless fully recovered. 12. Therapy with another photosensitizing agent in parallel or during the last 4 weeks. 13. Coexisting ophthalmic disease likely to require slit-lamp examination within the next 30 days. 14. Patients with known CNS metastases coming along with neurologic signs or symptoms. 15. Patients with psychiatric or other disorders that would interfere with their ability to give written informed consent. 16. Patients who are unable or unwilling to meet the requirements of the protocol. 17. Patients with a known history of drug, medication or alcohol abuse. 18. Patients participating in another study with an investigational medicinal product within less than one month prior to inclusion in the study. 19. Patients with any other condition which is considered by the investigator to bear a high risk of interfering with the drug medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine safety and tolerability of a local photodynamic treatment using Fotolon ® as a photosensitizer in patients with endobronchial obstruction from progression or recurrence of non-small cell lung cancer (NSCLC). To determine the objective tumor response rate defined by improvement in bronchscopic luminal diameter (see guidelines).;Secondary Objective: To determine the clinical benefit based on symptoms like cough, hemoptysis, stridor, dyspnea, sputum production etc. evaluated by: • Clinical parameters (physical examination) • Determination of changes in pulmonary function tests. • Determination of the quality of life (based on a standardized questionnaire).;Primary end point(s): objective tumor response rate defined by improvement in bronchscopic luminal diameter;Timepoint(s) of evaluation of this end point: week 4 and 12 after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): arterial blood gas analysis, pulmonary function test, lung cancer symptom scale or quality of life questionnaire, hematology and clinical chemistry, Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status;Timepoint(s) of evaluation of this end point: 1, 4 and 12 weeks and after 6 months (follow-up) after treatment | — |
Countries
Germany
Contacts
Public ContactChief Executive Officer
Apocare Pharma GmbH
Outcome results
None listed