Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer

NCT02916745 | Completed Phase 1 Results DMC FDA Drug FDA Device

• 1 other identifier: CLI-PHO1601
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 7

Brief Summary

This research study is being conducted to assess the safety and feasibility of using a new developed bronchoscopic technology called electronavigational bronchoscopy to treat subjects with solid tumor in peripheral lung, who are inoperable or refused surgery. It will involve 10 sites in USA and Canada. Participation will last 6 months.

Conditions

Non-small Cell Lung Cancer (NSCLC); Lung Metastasis

Keywords

Non-small cell lung cancer; NSCLC; lung cancer; lung carcinoma; lung metastasis

Outcome Measures

Primary Outcomes (2)

• Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor

  Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.

  Day 3 post-treatment

• Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)

  The incidence of adverse events following navigational bronchoscopy-iPDT (interstitial-Photodynamic Therapy) will be presented as the primary safety indicator for this treatment.

  Up to 6 months

Secondary Outcomes (23)

• Tumor Response at 3 Months Post Photodynamic Therapy (PDT)

  Up to 3 months

• Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)

  Up to 6 months

• Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.

  up to day 0 (-14 to -1 days)

• Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).

  1 day

• Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)

  Day 3

Other Outcomes (2)

• Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.

  Baseline, 10 days post-treatment

• Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event

  Up to 6 months

Study Arms (1)

Photodynamic therapy-Photofrin

EXPERIMENTAL

Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.

Drug: Porfimer sodium; Device: Fiber optic

Interventions

Porfimer sodium DRUG

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). A light dose of 200 J/cm of diffuser length will be delivered.

Also known as: Photofrin

Photodynamic therapy-Photofrin

Fiber optic DEVICE

A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.

Photodynamic therapy-Photofrin

Eligibility Criteria

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

You may qualify if:

• Male or female aged 18 or older
• Diagnosed with histologically confirmed solid tumor located in the peripheral lung
• Not candidate for curative surgery, is unfit for surgery, or does not wish to undergo curative surgery
• May be candidate for, have failed, or does not wish to undergo radiation therapy
• The tumor is ≤ 3 cm in size and clearly observable in computerized tomography (CT scan)
• Able to sign an informed consent

You may not qualify if:

• Diagnostic of small cell lung cancer
• Solid tumor located in central lung
• Presence of concurrent non-solid malignancy
• Abnormal blood results
• Received chemotherapy/immunotherapy in the last 4 weeks
• Tumor invades a major blood vessel
• Porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to any of its excipients
• Planned surgical procedure within the next 90 days
• Coexisting ophthalmic disease likely to require slit-lamp examination within the next 90 days
• Acute or chronic medical or psychological illnesses that prevent endoscopy procedures
• Pregnant or intend to become pregnant, breastfeeding or intend to breastfeed during the study
• Received PDT during the past 3 months
• Severe impairment of your kidney or liver function
• Participates or intends to participate in another drug study (other than observational studies) during the study

Sponsors & Collaborators

• Concordia Laboratories Inc.: lead

Study Sites (7)

University of Florida

Gainesville, Florida, 32611, United States

Location

Southeastern Regional Medical Center

Atlanta, Georgia, 30265, United States

Location

Alexian Brothers Hospital Network

Elk Grove Village, Illinois, 60007, United States

Location

Southwestern Regional Medical Center

Tulsa, Oklahoma, 74133, United States

Location

Providence Medical Research Center

Spokane, Washington, 99204, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53715, United States

Location

Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Dihematoporphyrin Ether; Optical Fibers

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; 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

Limitations and Caveats

Early termination of the study lead to small numbers of subject being analysed.

Results Point of Contact

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

kmcdonald-taylor@rogers.com

647-267-2942

Study Officials

• Michelle Depot, Ph.D.

  at the request of Concordia Laboratories Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 27, 2016
• Study Start: January 26, 2017
• Primary Completion: April 12, 2019
• Study Completion: April 12, 2019
• Last Updated: March 4, 2020
• Results First Posted: January 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); CA (1)