Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer

Study summary

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with stage 0 non-small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedHPPH

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 4, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Roswell Park Cancer Institute

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Roswell Park Cancer Institute
Interventions being studied: Drug: HPPH

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

DISEASE CHARACTERISTICS:
Biopsy confirmed carcinoma in situ (CIS) or microinvasive bronchogenic non-small cell lung carcinoma
May have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma histology
Stage 0 (CIS or microinvasive) disease, meeting all of the following criteria:
Lesion must be radiographically occult and not definable by conventional CT scan of the chest
Lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on laser-induced fluorescence emission (LIFE) bronchoscopy
Biopsy of the lesion must indicate no evidence of invasion beyond cartilage on histopathology, but may be invasive through the basement membrane (microinvasive carcinoma)
No evidence of major pulmonary vessel encasement on CT scan of the chest PATIENT CHARACTERISTICS:
Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
Platelet count ≥ 100,000/mm\^3
WBC ≥ 4,000/mm\^3
Prothrombin time ≤ 1.5 times upper limit of normal (ULN)
Total bilirubin ≤ 3.0 mg/dL
Creatinine ≤ 3.0 mg/dL
Alkaline phosphatase (hepatic) or SGOT ≤ 3 times ULN
No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
No severe chronic obstructive pulmonary disease, that in the opinion of the investigator, would preclude multiple bronchoscopies or partial central airway obstruction from mucous/debris formation
Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous or debris formation at the site of treatment
No contraindications for bronchoscopy
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
Prior therapy of any type (e.g., chemotherapy or radiotherapy) allowed for lung cancer

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

Study sites

U.S. locations

Roswell Park Cancer InstituteBuffalo, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 4, 2023. Always confirm current availability with the study team.

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