Photodynamic Therapy During Surgery in Treating Patients With Non-small Cell Lung Cancer That Can Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT01854684|
Recruitment Status : Recruiting
First Posted : May 15, 2013
Last Update Posted : March 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 21, 2014|
|Estimated Primary Completion Date :||April 30, 2018|
|Estimated Study Completion Date :||September 21, 2018|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|