Photodynamic Therapy During Surgery in Treating Patients With Non-small Cell Lung Cancer That Can Be Removed by Surgery
|Recurrent Non-Small Cell Lung Carcinoma Stage IIA Non-Small Cell Lung Carcinoma Stage IIB Non-Small Cell Lung Carcinoma Stage IIIA Non-Small Cell Lung Cancer Stage IIIB Non-Small Cell Lung Cancer||Drug: Temoporfin Procedure: Therapeutic Conventional Surgery Drug: Photodynamic Therapy Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) With Temoporfin in Patients With Resectable Primary Non-small Cell Lung Cancer (NSCLC) With Ipsilateral Thoracic Nodal (N1 or N2) or T3/T4 Disease|
- Maximum tolerated dose of PDT with temoporfin, defined as the dose level in which more than 1 of 6 patients experience a dose limiting toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: 2 weeks ]
- Locoregional recurrence-free rate [ Time Frame: Up to 2 years ]Estimated using simple relative frequencies. The corresponding 95% confidence interval for the estimated probability will be computed using the method proposed by Clopper and Pearson. Maximum likelihood estimation will be utilized in the model fitting procedures.
- Overall survival [ Time Frame: Up to 2 years ]Distribution will be obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
- Progression free survival [ Time Frame: Up to 2 years ]Distribution will be obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
- Toxicity rate, using NCI CTCAE version 4 [ Time Frame: Up to 30 days after completion of study treatment ]Estimated using simple relative frequencies. The corresponding 95% confidence interval for the estimated probability will be computed using the method proposed by Clopper and Pearson. Maximum likelihood estimation will be utilized in the model fitting procedures.
|Actual Study Start Date:||February 21, 2014|
|Estimated Study Completion Date:||September 21, 2018|
|Estimated Primary Completion Date:||September 21, 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (surgery and intraoperative PDT)
Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT.
Other Names:Procedure: Therapeutic Conventional Surgery
Undergo surgical resectionDrug: Photodynamic Therapy
Undergo intraoperative PDT
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
Other Name: pharmacological studies
I. To demonstrate that intraoperative adjuvant regional photodynamic therapy with low-dose temoporfin is safe.
I. Initial assessment of efficacy (i.e., 2-year disease free survival). II. To investigate the relationship between signal transducer and activator of transcription 3 (STAT3) levels, measured light dose and the clinical outcome.
III. Correlate the serum concentrations of vitamin D metabolites (25-hydroxyvitarnin D3 and 1,25-dihydroxyvitamin D3) with the presence of lymph node (LN) metastasis at the time of surgical resection.
IV. To measure temoporfin uptake in malignant and normal tissue.
OUTLINE: This is a dose-escalation study of photodynamic therapy with temoporfin.
Patients receive temoporfin intravenously (IV) over no less than 6 minutes and then undergo standard surgical resection with intraoperative photodynamic therapy (PDT).
After completion of study treatment, patients are followed up every 6 months for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01854684
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Roswell Park 877-275-7724 ASKRPCI@roswellpark.org|
|Principal Investigator: Chukwumere E. Nwogu|
|Principal Investigator:||Chukwumere Nwogu||Roswell Park Cancer Institute|