Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer
Study Details
Study Description
Brief Summary
This Phase I/Ila 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
PRIMARY OBJECTIVES PHASE 1:
- 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 locally advanced lung cancer (LALC) in the central airway, using porfimer sodium as a photosensitizer.
PRIMARY OBJECTIVE Phase II
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- To assess the tumor response to treatment.
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II To observe changes in well being
SECONDARY OBJECTIVES:
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- To evaluate local progression-free survival (PFS).
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II.To compare the treatment planning in DOSIE™ with the plan generated in COMSOL™
EXPLORATORY OBJECTIVES:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (porfimer sodium, EBUS, and photodynamic therapy) 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. |
Drug: Porfimer Sodium
Given IV
Other Names:
Procedure: Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy
Undergo EBUS-TBN guided I-PDT
Other Names:
|
Outcome Measures
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 [Up to 4 weeks]
- Tumor response rate - Phase II study [up to 24 weeks]
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 [From initiation of treatment to time of first observed diseased progression or death assessed up to 24 weeks]
Will be summarized using standard Kaplan-Meier methods, with median PFS and specified PFS rates estimated with 95% confidence intervals.
Other Outcome Measures
- Porfimer sodium retention in the target tumor tissue [Up to 24 weeks]
Will be descriptively summarized with mean +/- standard deviations.
- Immune biomarkers measured with Spearman rank correlation [Up to 24 weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Eligibility checklist before registration requires review of case by study surgeon or interventional pulmonologists to approve anatomic feasibility of an airway intervention
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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
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Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
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Platelets >= 100,000 cells/mm3 (International System of Units [SI] units 100 x 109/L).
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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.
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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:
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Participants who have had radiotherapy to the target tumor within 4 weeks prior to the scheduled I-PDT and/or PDT.
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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.
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Pregnant or nursing female participants.
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Co-existing ophthalmic disease likely to require slit-lamp examination within 14 days following I-PDT and/or PDT treatment.
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Known hypersensitivity/allergy to porphyrin.
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Patients who are not cleared by the anesthesiologist to undergo an advanced bronchoscopy procedure under general anesthesia.
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Patients diagnosed with porphyria.
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Unwilling or unable to follow protocol requirements.
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Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
Sponsors and Collaborators
- Roswell Park Cancer Institute
- National Cancer Institute (NCI)
- Pinnacle Biologics Inc.
- Simphotek Inc.
Investigators
- Principal Investigator: Nathaniel Ivanick, MD, Roswell Park Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I 279415
- NCI-2018-01969
- I 279415
- 1R44CA265656