Locally Advanced Lung Carcinoma, Non-Small Cell Lung Carcinoma, Small Cell Lung Carcinoma, Solid Tumor, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
Conditions
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 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.
Interventions
DRUGPorfimer Sodium
Given IV
PROCEDUREUltrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy
Undergo EBUS-TBN guided I-PDT
Sponsors
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Pinnacle Biologics Inc.
Simphotek Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 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 | Number of Participants with Adverse Events That Are \>= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0 |
| Number of Participants With Tumor Response | up to 24 weeks | Will be reported using frequencies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 progression-free survival (PFS) estimated with 95% confidence intervals. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNathaniel Ivanick, MD
Roswell Park Cancer Institute
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Porfimer Sodium, EBUS, and Photodynamic Therapy) Patients received IV of 2 mg/kg porfimer sodium over 3-5 minutes and 48 hours +/- 4 prior the I-PDT. Patients then undergo EBUS-TBN guided I-PDT over a few hours.
Porfimer Sodium: Given IV Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy: Undergo EBUS-TBN guided I-PDT | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Treatment (Porfimer Sodium, EBUS, and Photodynamic Therapy) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 63 years STANDARD_DEVIATION 13.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 17 / 19 |
| other Total, other adverse events | 16 / 19 |
| serious Total, serious adverse events | 12 / 19 |
Outcome results
Primary
Number of Participants With Adverse Events That Are >= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
Number of Participants with 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
Population: All treated and eligible patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Porfimer Sodium, EBUS, and Photodynamic Therapy) | Number of Participants With Adverse Events That Are >= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0 | 6 Participants |
Primary
Number of Participants With Tumor Response
Will be reported using frequencies
Time frame: up to 24 weeks
Population: All treated and eligible patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Porfimer Sodium, EBUS, and Photodynamic Therapy) | Number of Participants With Tumor Response | 0 participants |
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 progression-free survival (PFS) estimated with 95% confidence intervals. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: From initiation of treatment to time of first observed diseased progression or death assessed up to 24 weeks
Population: All treated and eligible patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Porfimer Sodium, EBUS, and Photodynamic Therapy) | Progression-free Survival (PFS) Assessed Using Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | 2.6 months |