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

Last updated: March 28, 2025
Sponsor: Roswell Park Cancer Institute
Overall Status: Terminated

Phase

1/2

Condition

Carcinoma

Neuroblastoma

Non-small Cell Lung Cancer

Treatment

Porfimer Sodium

Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy

Clinical Study ID

NCT03735095
I 279415
1R44CA265656
I 279415
NCI-2018-01969
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • > 18 year olds

  • Eligibility checklist before registration requires review of case by study surgeonor interventional pulmonologists to approve anatomic feasibility of an airwayintervention

  • For patients in Cohort B only. Patients are amenable to receive a palliativeradiotherapy of 8 Gy x1 48±4 h prior to the I-PDT, as determined by the radiationoncologist

  • Patients with an established pathologic diagnosis of small cell and/or non-smallcell lung cancer or other malignancies causing airway obstruction > 25% requiringbronchoscopic intervention. Or inoperable malignancies not candidates for curativeradiotherapy 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 contraceptivemethods (e.g., hormonal or barrier method of birth control; abstinence) prior tostudy entry. Should a woman become pregnant or suspect she is pregnant while she orher partner is participating in this study, she should inform her treating physicianimmediately.

  • Participant must understand the investigational nature of this study and sign anIndependent Ethics Committee/Institutional Review Board approved written informedconsent form prior to receiving any study related procedure.

Exclusion

Exclusion Criteria:

  • Participants who have had radiotherapy to the target tumor within 4 weeks prior tothe scheduled I-PDT and/or PDT.

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.

  • Pregnant or nursing female participants.

  • Co-existing ophthalmic disease likely to require slit-lamp examination within 14days following I-PDT and/or PDT treatment.

  • Known hypersensitivity/allergy to porphyrin.

  • Patients who are not cleared by the anesthesiologist to undergo an advancedbronchoscopy procedure under general anesthesia.

  • Patients with target tumor invading into the lumen of the esophagus, confirmed byesophago-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 anunsuitable candidate to receive I-PDT or PDT.

Study Design

Total Participants: 19
Treatment Group(s): 2
Primary Treatment: Porfimer Sodium
Phase: 1/2
Study Start date:
February 12, 2020
Estimated Completion Date:
July 26, 2024

Study 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 delivery of I-PDT. 20 minutes 48 hours +/- 4 hours before receiving I-PDT. I-PDT is then received over 1-2 hours.

After completion of study treatment, patients are followed up at 4, 8, 12, and 24 weeks.

Connect with a study center

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

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