CompletedPhase 1NCT01854684

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

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.

Checked against the public recordLast updated Jul 22, 2022 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations1
SponsorRoswell Park Cancer Institute
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Roswell Park Cancer Institute
Interventions being studied
Drug: Temoporfin; Procedure: Therapeutic Conventional Surgery; Drug: Photodynamic Therapy; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Roswell Park Cancer InstituteBuffalo, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 22, 2022. Always confirm current availability with the study team.

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