Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer
Primary Purpose
Locally Advanced Lung Carcinoma, Non-Small Cell Lung Carcinoma, Small Cell Lung Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Porfimer Sodium
Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Lung Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Eligibility checklist before registration requires review of case by study surgeon or interventional pulmonologists to approve anatomic feasibility of an airway intervention
- Patients with a diagnosis of small cell and/or non-small cell lung cancer or other malignancy that metastasize to the lung causing airway obstruction > 25% requiring bronchoscopic intervention
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
- Platelets >= 100,000 cells/mm^3 (International System of Units [SI] units 100 x 10^9/L).
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
Exclusion Criteria:
- Participants who have had radiotherapy to the target tumor within 4 weeks prior to the scheduled I-PDT and/or PDT.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or nursing female participants.
- Co-existing ophthalmic disease likely to require slit-lamp examination within 14 days following I-PDT and/or PDT treatment.
- Known hypersensitivity/allergy to porphyrin.
- Patients who are not cleared by the anesthesiologist to undergo an advanced bronchoscopy procedure under general anesthesia.
- Patients diagnosed with porphyria.
- Unwilling or unable to follow protocol requirements.
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
Sites / Locations
- Roswell Park Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (porfimer sodium, EBUS, and photodynamic therapy)
Arm Description
Patients receive porfimer sodium IV over 20 minutes 2-4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over 30-45 minutes.
Outcomes
Primary Outcome Measures
Incidence of adverse events that are >= grade 4 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0
Tumor response rate - Phase II study
Will be reported using frequencies and relative frequencies
Secondary Outcome Measures
Progression-free survival (PFS) assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Will be summarized using standard Kaplan-Meier methods, with median PFS and specified PFS rates estimated with 95% confidence intervals.
Full Information
NCT ID
NCT03735095
First Posted
November 5, 2018
Last Updated
September 21, 2023
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI), Pinnacle Biologics Inc., Simphotek Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03735095
Brief Title
Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer
Official Title
Endobronchial Ultrasound Transbronchial Needle Guided Interstitial Photodynamic Therapy for Palliation of Locally Advanced Lung Cancer and Advanced Cancers Obstructing the Airway -Phase I/II
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
February 12, 2030 (Anticipated)
Study Completion Date
February 12, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI), Pinnacle Biologics Inc., Simphotek Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This Phase I/Il studies the side effects of endobronchial ultrasound guided interstitial photodynamic therapy work in treating patients with lung cancer that has spread to nearby tissues or lymph nodes. Photodynamic therapy consists of injecting a light sensitive drug called a photosensitizer, such as porfimer sodium, into the vein, waiting for it to accumulate in the tumor, and then activating it with a red laser light. Giving photodynamic therapy with Porfimer sodium may reduce the tumor size in patients with lung cancer.
Detailed Description
PRIMARY OBJECTIVES PHASE 1:
I. To evaluate the safety and potential efficacy of endobronchial ultrasound with transbronchial needle (EBUS-TBN) guided interstitial photodynamic therapy (EBUS-TBN I-PDT) and/or I-PDT and/or photodynamic therapy (PDT) in patients with malignant airway obstructions using porfimer sodium as a photosensitizer.
PRIMARY OBJECTIVE Phase II
I. To assess the tumor response to treatment.
II To observe changes in well being
SECONDARY OBJECTIVES:
I. To evaluate local progression-free survival (PFS).
II.To compare the treatment planning in DOSIE™ with the plan generated in COMSOL™ - COHORT A ONLY
III. To measure changes in tumor pO2, optical properties, and irradiance and fluence in relationship to response
EXPLORATORY OBJECTIVES:
I. Examine porfimer sodium retention in the target tumor tissue. II. Examine the relationship between immune biomarkers and response.
OUTLINE:
Patients receive Porfimer sodium intravenously (IV) over 20 minutes 2-4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over 30-45 minutes.
After completion of study treatment, patients are followed up at 4, 8, 12, and 24 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Lung Carcinoma, Non-Small Cell Lung Carcinoma, Small Cell Lung Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment (porfimer sodium, EBUS, and photodynamic therapy)
Arm Type
Experimental
Arm Description
Patients receive porfimer sodium IV over 20 minutes 2-4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over 30-45 minutes.
Intervention Type
Drug
Intervention Name(s)
Porfimer Sodium
Other Intervention Name(s)
Photofrin
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy
Other Intervention Name(s)
Endobronchial Ultrasound with Transbronchial Needle (EBUS-TBN) Guided Interstitial PDT (IPDT); Endobronchial Ultrasound Transbronchial Needle-Guided Interstitial Photodynamic Therapy, Ultrasound-Guided Transbronchial Needle-Guided Interstitial Photodynamic Therapy; EBUS-TBN Interstitial Photodynamic Therapy; EBUS-TBN IPDT
Intervention Description
Undergo EBUS-TBN guided I-PDT
Primary Outcome Measure Information:
Title
Incidence of adverse events that are >= grade 4 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0
Time Frame
Up to 4 weeks
Title
Tumor response rate - Phase II study
Description
Will be reported using frequencies and relative frequencies
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS) assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Description
Will be summarized using standard Kaplan-Meier methods, with median PFS and specified PFS rates estimated with 95% confidence intervals.
Time Frame
From initiation of treatment to time of first observed diseased progression or death assessed up to 24 weeks
Other Pre-specified Outcome Measures:
Title
Porfimer sodium retention in the target tumor tissue
Description
Will be descriptively summarized with mean +/- standard deviations.
Time Frame
Up to 24 weeks
Title
Immune biomarkers measured with Spearman rank correlation
Description
Will examine the relationship between immune biomarkers and response. Will correlate immune biomarkers and tumor response measures using the Spearman rank correlation and corresponding 95% confidence interval.
Time Frame
Up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligibility checklist before registration requires review of case by study surgeon or interventional pulmonologists to approve anatomic feasibility of an airway intervention
For patients in Cohort B only. Patients are amenable to receive a palliative radiotherapy of 8 Gy x1 48±4 h prior to the I-PDT, as determined by the radiation oncologist
Patients with an established pathologic diagnosis of small cell and/or non-small cell lung cancer or other malignancies causing airway obstruction > 25% requiring bronchoscopic intervention. Or inoperable malignancies not candidates for curative radiotherapy within the airway.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
Platelets >= 100,000 cells/mm^3 (International System of Units [SI] units 100 x 10^9/L).
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
Exclusion Criteria:
Participants who have had radiotherapy to the target tumor within 4 weeks prior to the scheduled I-PDT and/or PDT.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or nursing female participants.
Co-existing ophthalmic disease likely to require slit-lamp examination within 14 days following I-PDT and/or PDT treatment.
Known hypersensitivity/allergy to porphyrin.
Patients who are not cleared by the anesthesiologist to undergo an advanced bronchoscopy procedure under general anesthesia.
Patients with target tumor invading into the lumen of the esophagus, confirmed by esophago-gastro-duodenoscopy (EGD) with endoscopic ultrasound
Patients diagnosed with porphyria.
Unwilling or unable to follow protocol requirements.
Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive I-PDT or PDT.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel Ivanick, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathaniel Ivanick, MD
Phone
716-845-8675
Email
Nathaneil.Ivanick@RoswellPark.org
First Name & Middle Initial & Last Name & Degree
Nathanel Ivanick, MD
12. IPD Sharing Statement
Learn more about this trial
Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer
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