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

Roswell Park Comprehensive Cancer Center logo

Roswell Park Comprehensive Cancer Center

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Solid Tumor
Non-Small Cell Lung Carcinoma
Stage IIIB Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage III Lung Cancer AJCC v8
Locally Advanced Lung Carcinoma
Stage IIIC Lung Cancer AJCC v8
Small Cell Lung Carcinoma

Treatments

Procedure: Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy
Drug: Porfimer Sodium

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT03735095
NCI-2018-01969 (Registry Identifier)
1R44CA265656 (U.S. NIH Grant/Contract)
I 279415 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • > 18 year olds
  • 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

Treatment (porfimer sodium, EBUS, and photodynamic therapy)
Experimental group
Description:
Treatment (porfimer sodium, EBUS, and photodynamic therapy) Patients receive 2 mg/kg porfimer sodium IV over 3-5 minutes 48 +/- 4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over few hours.
Treatment:
Drug: Porfimer Sodium
Procedure: Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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