Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer

Small Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03735095
• Other study ID #: I 279415
• Secondary ID: NCI-2018-01969I
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 12, 2020
• Est. completion date: February 12, 2030

Study information

• Verified date: September 2023
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: February 12, 2030
• Est. primary completion date: February 12, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Locally Advanced Lung Carcinoma
• Lung Neoplasms
• 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

Intervention

Drug:
• Porfimer Sodium
Given IV

Procedure:
• Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy
Undergo EBUS-TBN guided I-PDT

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (4)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI), Pinnacle Biologics Inc., Simphotek Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Porfimer sodium retention in the target tumor tissue	Will be descriptively summarized with mean +/- standard deviations.	Up to 24 weeks
Other	Immune biomarkers measured with Spearman rank correlation	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.	Up to 24 weeks
Primary	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		Up to 4 weeks
Primary	Tumor response rate - Phase II study	Will be reported using frequencies and relative frequencies	up to 24 weeks
Secondary	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.	From initiation of treatment to time of first observed diseased progression or death assessed up to 24 weeks