A Phase 1 interventional study of Temoporfin and Therapeutic Conventional Surgery in Recurrent Non-Small Cell Lung Carcinoma, Stage IIA Non-Small Cell Lung Carcinoma and Stage IIB Non-Small Cell Lung Carcinoma, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-22.
Sponsored by Roswell Park Cancer Institute · Phase 1, Interventional, and Treatment
This phase I trial studies the side effects and best dose of photodynamic therapy during surgery in treating patients with non-small cell lung cancer that can be removed by surgery. Photodynamic therapy uses a drug, such as temoporfin, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be a better way to treat patients with non-small cell lung cancer.
PRIMARY OBJECTIVES:
I. To demonstrate that intraoperative adjuvant regional photodynamic therapy with low-dose temoporfin is safe.
SECONDARY OBJECTIVES:
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.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's enrollment of 8 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Roswell Park Cancer Institute is the lead sponsor of 417 studies on the registry; 64 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
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Exclusion Criteria:
Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT.
Drug: Temoporfin · Procedure: Therapeutic Conventional Surgery · Drug: Photodynamic Therapy · Other: Laboratory Biomarker Analysis · Other: Pharmacological Study
Given IV
Also known as: Foscan, mTHPC
Undergo surgical resection
Undergo intraoperative PDT
Also known as: Light Infusion Therapy™, PDT, Photoradiation Therapy
Correlative studies
Correlative studies
Also known as: 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
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.
Time frame: Up to 2 years
Overall survival
Distribution will be obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
Time frame: Up to 2 years
Progression free survival
Distribution will be obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
Time frame: Up to 2 years
Toxicity rate, using NCI CTCAE version 4
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.
Time frame: Up to 30 days after completion of study treatment
Ran from Feb 2014 to primary completion in Sep 2018, 54 months.
Of 206 non-industry phase 1 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 80. This study's 54 months is close to that.
Counting every sponsor, half of 588 studies reached it within 51 months; a quarter within 31 and three quarters within 74.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Temoporfin
Carcinoma, Non-Small-Cell Lung →
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