Photodynamic Therapy During Surgery in Treating Patients With Non-small Cell Lung Cancer That Can Be Removed by Surgery

Stage IIIB Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854684
• Other study ID #: I 228112
• Secondary ID: NCI-2013-00886I
• Status: Completed
• Phase: Phase 1
• Start date: February 21, 2014
• Est. completion date: September 4, 2018

Study information

• Verified date: July 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 4, 2018
• Est. primary completion date: September 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed non-small cell lung cancer (NSCLC)

• Patients with resectable primary NSCLC who are undergoing surgery to resect T3 to T4 lesions OR any patients with clinical NI or N2 disease regardless of T-stage

• 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

• Must consent to participate in study I 03103: Roswell Park Cancer Institute (RPCI) Data Bank and Biorepository (DBBR)

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

• Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds

• White blood cell (WBC) < 4,000

• Platelet count < 100,000

• Total serum bilirubin > 2 mg/dL

• Serum creatinine > 2 mg/dL

• Alkaline phosphatase (hepatic) or serum glutamic oxaloacetic transaminase (SGOT) > 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 study drug

• Received an investigational agent within 30 days prior to enrollment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• 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

Intervention

Drug:
• Temoporfin
Given IV

Procedure:
• Therapeutic Conventional Surgery
Undergo surgical resection

Drug:
• Photodynamic Therapy
Undergo intraoperative PDT

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Pharmacological Study
Correlative studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 weeks
Secondary	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.	Up to 2 years
Secondary	Overall survival	Distribution will be obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.	Up to 2 years
Secondary	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.	Up to 2 years
Secondary	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.	Up to 30 days after completion of study treatment