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Completed

NCT Number: NCT00526461

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

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 information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

About this study

OBJECTIVES:

Primary

  • To determine the maximally tolerated light dose (MTID) in patients with bronchogenic carcinoma in situ (CIS) or bronchogenic microinvasive carcinoma.
  • To identify the systemic and normal tissue toxicity resulting from photodynamic therapy using HPPH in these patients.

Secondary

  • To study tumor response in these patients.

OUTLINE: Patients receive HPPH IV over 1 hour on day 1. Approximately 2 days later, patients undergo photodynamic therapy (PDT) using laser light passed through the biopsy channel of an endoscope. Patients undergo endoscopic debridement on day 5. If viable tumor is found outside of the initial treatment area, patients may receive another dose of laser light without additional HPPH at that time.

After completion of study treatment, patients are followed at 4-6 weeks, 6 months, and periodically thereafter.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPPH

Drug

IV

Primary outcomes

  1. Toxicity as measured by NCI CTC v2.0

    Time frame: Daily while in-house, weekly after discharge, at 4-6 weeks and at 6 months

Secondary outcomes

  1. Tumor response

    Time frame: At 4-6 weeks and 6 months

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

A Phase I Study Light Dose for Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-Small Cell Carcinoma in Situ or Non-Small Cell Microinvasive Bronchogenic Carcinoma: A Dose Ranging Study

Important dates

Study start
2004
Primary completion
2013
Study completion
2014
First posted
Sep 10, 2007
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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