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Photodynamic Therapy in Treating Patients With Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Photodynamic Therapy in Treating Patients With Lung Cancer

A Phase I Study of Light Dose for Photodynamic Therapy(PDT) Using 2-[ 1-hexyloxyethel]-2-devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-small Cell Carcinoma in Situ or Non-small Cell Microinvasive Carcinoma. A Dose Ranging Study

NCT01668823•Roswell Park Cancer Institute

View on ClinicalTrials.gov

Summary

This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with lung cancer. Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed.

Detailed Description

PRIMARY OBJECTIVES: I. To determine maximally tolerated light dose (MTID). Identify systemic and normal tissue toxicity using 2-\[hexyloxyethyl)-2-devinyl pyropheophorbide-a (HPPH) for photodynamic therapy in patients with bronchogenic carcinoma-in-situ (CIS) or microinvasive carcinoma. SECONDARY OBJECTIVES: I. To study tumor response in patients with bronchogenic carcinoma-in-situ (CIS) or bronchogenic microinvasive carcinoma. OUTLINE: This is a dose-escalation study. Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5. After completion of study treatment, patients are followed up at 4-6 weeks, 6 months, and then periodically for at least 2 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with biopsy confirmed carcinoma-in-situ (CIS) or microinvasive lung cancer
•Patients may have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma
•Patients may have received prior therapy for lung cancer of any type, e.g. chemotherapy, radiation therapy
•Patients must have no contraindications for bronchoscopy
•Female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal
•Patients must have a Karnofsky scale 50 or above (Eastern Cooperative Oncology Group \[ECOG\] 0-2)
•Patients must sign an Informed Consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB)
•Patients with underlying lung disease must be judged (by the principal investigator) able to with stand mucous/debris formation at the site of treatment
•Definition of CIS or microinvasive lung cancer for this protocol: the lesion will be radiographically occult and not definable by conventional computed tomography (CT) of the chest; the lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on lung imaging fluorescence endoscope (LIFE) bronchoscopy; biopsies of the lesion must indicate no evidence of invasion beyond cartilage on histopathology; the lesion may, however, be invasive through the basement membrane (microinvasive carcinoma)

Exclusion Criteria

•Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
•White blood cells (WBC) \< 4000
•Platelet count \< 100,000
•Prothrombin time exceeding 1.5 times the upper normal limit
•Total serum bilirubin \> 3.0 mg/dl
•Serum creatinine \> 3.0 mg/dl
•Alkaline phosphatase (hepatic) or serum glutamic oxaloacetic transaminase (SGOT) \> 3 times the upper normal limit
•Severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude multiple bronchoscopies or partial central airway obstruction from mucous/debris formation
•Any evidence of worsening pulmonary symptoms or COPD exacerbation
•Evidence of major pulmonary vessel encasement on CT scan of the chest
+1 more criteria

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Key Dates

Start Date

February 1, 2004

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2014

Last Updated

July 31, 2014

Enrollment

ACTUAL participants

Conditions

Adenocarcinoma of the LungLarge Cell Lung CancerRecurrent Non-small Cell Lung CancerSquamous Cell Lung CancerStage 0 Non-small Cell Lung Cancer

Interventions

HPPH

DRUG

photodynamic therapy

DRUG

therapeutic bronchoscopy

PROCEDURE

A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer

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Recurrent Non-small Cell Lung Cancer

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WITHDRAWNPHASE1/PHASE2

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Carcinoma, Non-Small-Cell LungMetastatic Non Small Cell Lung Cancer+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Photodynamic Therapy in Treating Patients With Lung Cancer

Inclusion Criteria

Exclusion Criteria

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