Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery
Published: September 21, 2018
Primary Outcome Measures
- Incidence of adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: Up to 30 days ]
The frequency of toxicities will be tabulated by grade across all dose levels and cycles. All subjects who receive any study treatment will be considered evaluable for toxicity.
Secondary Outcome Measures
- Progression-free survival [ Time Frame: From time of surgery + photodynamic therapy (PDT) or, until start of a new treatment, disease progression or death (whichever occurs first), assessed up to 3 years ]
The estimated distribution of progression free survival will be obtained using the Kaplan-Meier method. Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
- Overall survival (OS) [ Time Frame: From the time of treatment (surgery + PDT) until death from any cause, assessed up to 3 years ]
Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
- Anti tumor response [ Time Frame: Up to 2 years ]
Monitor immune markers for correlation between the IO PDT treatments and local or distant disease recurrence
- Inclusion Criteria
- Histologically confirmed mesothelioma or non-small cell lung cancer (NSCLC) with pleural disease without distant disease.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) scale of 0-2.
- 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 or legal representative 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.
- Exclusion Criteria
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients with known 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.
- White blood cell (WBC) < 4,000.
- Platelet count < 100,000.
- Total serum bilirubin > 2 mg/dL.
- Serum creatinine > 2 mg/dL.
- Alkaline phosphatase > 3 times the upper normal limit.
- Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) > 3 times the upper normal limit.
- 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.
- Received an investigational agent within 30 days prior to enrollment.