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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00526461
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : May 7, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

September 5, 2007
September 10, 2007
May 7, 2014
February 2004
June 2013   (Final data collection date for primary outcome measure)
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 ]
Toxicity as measured by NCI CTC v2.0
Complete list of historical versions of study NCT00526461 on Archive Site
Tumor response [ Time Frame: At 4-6 weeks and 6 months ]
Tumor response
Not Provided
Not Provided
Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer
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

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.



  • 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.


  • 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.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Cancer
Drug: HPPH
Experimental: PDT using HPPH
Patients receive HPPH IV over 1 hour on day 1. Patients then receive photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.
Intervention: Drug: HPPH
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2014
June 2013   (Final data collection date for primary outcome measure)


  • 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


  • 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


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Samjot Dhillon, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP