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

NCT01854684 | Completed Phase 1

• 2 other identifiers: I 228112NCI-2013-00886
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Locoregional recurrence-free rate

  Up to 2 years

• Overall survival

  Up to 2 years

• Progression free survival

  Up to 2 years

• Toxicity rate, using NCI CTCAE version 4

  Up to 30 days after completion of study treatment

Study Arms (1)

Treatment (surgery and intraoperative PDT)

EXPERIMENTAL

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

Interventions

Temoporfin DRUG

Given IV

Also known as: Foscan, mTHPC

Treatment (surgery and intraoperative PDT)

Therapeutic Conventional Surgery PROCEDURE

Undergo surgical resection

Treatment (surgery and intraoperative PDT)

Photodynamic Therapy DRUG

Undergo intraoperative PDT

Also known as: Light Infusion Therapy™, PDT, Photoradiation Therapy

Treatment (surgery and intraoperative PDT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (surgery and intraoperative PDT)

Pharmacological Study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (surgery and intraoperative PDT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

temoporfin; Photochemotherapy; 1-phenyl-3,3-dimethyltriazene; Phototherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Chukwumere Nwogu

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 15, 2013
• Study Start: February 21, 2014
• Primary Completion: September 4, 2018
• Study Completion: September 4, 2018
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

US (1)