Status:
COMPLETED
Photodynamic Therapy During Surgery in Treating Patients With Non-small Cell Lung Cancer That Can Be Removed by Surgery
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Recurrent Non-Small Cell Lung Carcinoma
Stage IIA Non-Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 thera...
Detailed 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-y...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 21 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01854684
Start Date
February 21 2014
End Date
September 4 2018
Last Update
July 22 2022
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263