- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04836429
Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-small Cell Lung Cancer With Pleural Disease
Utilizing Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC) With Pleural Disease or Malignant Pleural Mesothelioma (MPM) - Phase I Study
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: ASK Roswell
- Phone Number: 1-800-767-9355
- Email: askroswell@roswellpark.org
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
-
Principal Investigator:
- Saikrishna S. Yendamuri
-
Contact:
- Saikrishna S. Yendamuri
- Phone Number: 716-845-8675
- Email: Sai.Yendamuri@RoswellPark.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologically confirmed non-small cell lung cancer (NSCLC) with pleural disease and PDL1 expression < 50% or histologically confirmed diagnosis of malignant pleural mesothelioma not candidates for macroscopic complete resection
Adequate blood tests 14 days prior to intraoperative PDT and with values within the ranges specified below.
- Hemoglobin ≥ 9.0 g/L
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except participants with Gilbert's Syndrome, who are eligible with bilirubin ≤ 2.5 ULN)
- Alanine transaminase ≤ 2.5 xupper limit of normal (ULN), unless liver metastases or invasion are present, in which case it must be ≤ 5 x ULN
- Aspartate aminotransferase ≤ 2.5 x ULN, unless liver metastases or invasion are present, in which case it must be ≤ 5 x ULN
- The patient is on standard of care immunotherapy or combination of chemotherapy and immunotherapy with no evidence of progression or a candidate for chemoimmunotherapy as determined by the treating medical oncologist. Eligible patients that are currently on standard of care treatment will have the systemic therapy paused for 4-6 weeks prior to the surgery and intraoperative PDT and will resumed within 4-12 weeks after surgery following standard of care timeframe utilized for restarting systemic therapy after major surgical procedures to ensure adequate post-op recovery and tissue healing.
- Age >= 18 years old
- Life expectancy of at least 12 weeks.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) score of 0 - 1
- Subjects 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 and for 6 months after surgery. 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
- The subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure
- Platelet count < 100,000
Exclusion Criteria:
- Patients who received chemotherapy, chemoimmunotherapy or radiotherapy within <4 weeks (6 weeks for nitrosoureas or mitomycin C) or those who have not recovered from reversible adverse events prior to the scheduled surgery and intraoperative PDT.
- Patients with untreated or symptomatically unstable treated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with treated and stable brain metastases (at least 28 days from last radiotherapy treatment) are eligible as long as steroids are not required for symptom management
Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
- Absolute neutrophil count < 1500
- Left ventricular ejection fraction (LVEF) < lower level of normal (LLN)
- Total bilirubin > 2 mg/dL
- Creatinine clearance < 60 mL/min (Cockcroft Gault equation)
- Alkaline phosphatase (hepatic) > 3 times the upper normal limit (SGPT) > 3 times the upper normal limit
- NOTE: Roswell Park clinical lab blood chemistry is performed on plasma unless otherwise indicated
- 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 subjects
- Unwilling or unable to follow protocol requirements
Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to receive porfimer sodium such as active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g. colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included
- Patients with celiac disease controlled by diet alone
- Patients with Hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Exceptions include past or resolved Hepatitis B (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) and patients positive for hepatitis C (HCV) antibody if polymerase chain reaction is negative for HCV RNA. HIV testing is not required in absence of clinical suspicion of HIV
- Received an investigational agent within 30 days prior to enrollment
- History of, or active autoimmune disorder, requiring systemic steroids or immunosuppressive agents. Exceptions allowed: patients with autoimmune dermatologic conditions not requiring systemic steroids or immunosuppressive agents (e.g. vitiligo, eczema, etc.), endocrine-related autoimmune conditions receiving appropriate hormonal supplementation. Use of immunosuppressant drugs such as steroids, azathioprine, tacrolimus, cyclosporine, etc. is not permitted within 4 weeks before recruitment (exception allowed is use of steroids as hormone replacement therapy or as supportive medication e.g. anti-emesis, contrast allergy, pre-medication, etc. or other short-course therapy less than 2 weeks continuously within 4 weeks of study treatment)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (porfimer sodium, photodynamic therapy)
Patients receive porfimer sodium IV over 3-5 minutes 24-48 hours prior to standard of care VATS, followed by photodynamic therapy
|
Given IV
Other Names:
Undergo VATS
Other Names:
Undergo photodynamic therapy
Other Names:
Subjects will receive one course of light therapy at the time of surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of serious adverse events (SAE)
Time Frame: 28 days post study-related immunotherapy
|
Will be determined by recording the occurrence of SAE during the first 28 days post study-related immunotherapy.
The SAE will be evaluated using the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
28 days post study-related immunotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: assessed up to 2 years
|
Will utilize Kaplan-Meier curves to descriptively examine dose level differences and generate summary statistics.
|
assessed up to 2 years
|
Overall survival (OS)
Time Frame: assessed up to 2 years
|
Will utilize Kaplan-Meier curves to descriptively examine dose level differences and generate summary statistics.
|
assessed up to 2 years
|
Changes in the immune phenotype of peripheral blood CD8+ T cells
Time Frame: Baseline up to 2 years
|
Will be analyzed using a repeated measures analysis-of-variance (ANOVA) model with a factor for dose level time and a dose level by time interaction.
|
Baseline up to 2 years
|
Changes in platelet-to-lymphocyte ratio
Time Frame: Baseline up to 2 years
|
Will be analyzed using a repeated measures ANOVA model with a factor for dose level, time and a dose level by time interaction.
|
Baseline up to 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: • Saikrishna Yendamuri, MD, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Pleural Diseases
- Antineoplastic Agents
- Photosensitizing Agents
- Dermatologic Agents
- Dihematoporphyrin Ether
- Trioxsalen
Other Study ID Numbers
- I 767720
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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