Safety of PDT-Photofrin® Prior to Lung Surgery

NCT03344861 | Completed Phase 1 Results DMC FDA Drug FDA Device

• 1 other identifier: CLI-PHO1701
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 8

Brief Summary

This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites in USA. Participation will last 4 months.

Conditions

Lung Cancer; Lung Cancer Metastatic

Keywords

lung cancer; lung carcinoma; lung metastases

Outcome Measures

Primary Outcomes (5)

• Safety: Number of Participants With at Least One Adverse Event

  Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.

  108 days (to 3 months post surgery)

• Safety: Physical Examination Summaries of Non-normal Findings for Each Subject

  Safety evaluation will include the physical examinations summary of non-normal findings for each subject.

  108 days (to 3 months post surgery)

• Safety: Vital Sign Summary of Abnormal Findings for Each Subject

  Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included.

  108 days (to 3 months post surgery)

• Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject

  Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed.

  108 days (to 3 months post surgery)

• Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject

  Safety evaluation will include incidence of skin photosensitivity summarized for each subject.

  108 days (to 3 months post surgery)

Secondary Outcomes (21)

• Macroscopic Tissue Examination

  Day 13 to 18

• Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery

  Day 13 to 18

• Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery

  Day 13 to 18

• Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery

  Day 13 to 18

• Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery

  Day 13 to 18

Study Arms (1)

Photodynamic therapy-Photofrin

EXPERIMENTAL

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Drug: Porfimer Sodium; Device: Fiber optic

Interventions

Porfimer Sodium DRUG

Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Also known as: Photofrin

Photodynamic therapy-Photofrin

Fiber optic DEVICE

After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Photodynamic therapy-Photofrin

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-79
• Diagnosed with primary or metastatic tumor \< 5 cm located in peripheral lung that can be completely resectable
• Candidate for surgical resection
• Candidate for bronchoscopy
• Tumor is accessible for unrestricted illumination of PDT
• Subject is deemed likely to survive for at least 3 months
• Non-menopausal/non-sterile female subject of childbearing potential has negative B-HCG (Human chorionic gonadotropin) at time of study entry
• Non-menopausal/non-sterile female subject of childbearing potential uses medically acceptable form of birth control
• Subject is able and willing to provide written informed consent to participate in the study, which must comply with ICH (International Council for Harmonisation) guidelines \& local requirements

You may not qualify if:

• Diagnosis of small cell lung cancer or carcinoid tumors
• Primary or metastatic lung tumor located in central lung or near vertebral body
• Tumor invades a major blood vessel
• Presence of concurrent non-solid malignancy
• Tumor previously treated with radiation therapy
• Chemotherapy in the last four weeks
• Tumor treated with PDT within the last 3 months
• Abnormal blood results
• Subject with porphyria or hypersensitivity to Photofrin
• Coexisting ophthalmic disease likely to required slit-lamp exam within next 90 days
• Acute or chronic medical or psychological illness as judged clinical significant to PI to preclude bronchoscopy procedures
• female who is breast-feeding or intends to breast-feed during study
• subject who participated in another study within last 30 days or intends to participate in another study during this study

Sponsors & Collaborators

• Concordia Laboratories Inc.: lead

Study Sites (8)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Cancer Treatment Centers of America/Southeastern

Atlanta, Georgia, 30265, United States

Location

AMITA Health Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

Dubois Medical Center

DuBois, Pennsylvania, 15801, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Providence Health & Services

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Dihematoporphyrin Ether; Optical Fibers

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Kim McDonald-Taylor
• Organization: on behalf of Concordia Laboratories Inc.

kmcdonald-taylor@rogers.com

647-267-2942

Study Officials

• Erin O'Neil

  Concordia Laboratories Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: August 14, 2017
• Primary Completion: March 22, 2019
• Study Completion: March 22, 2019
• Last Updated: January 13, 2020
• Results First Posted: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)