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

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: HPPH Phase 1

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2004
Actual Primary Completion Date : June 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.
Drug: HPPH

Primary Outcome Measures :
  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 Outcome Measures :
  1. Tumor response [ Time Frame: At 4-6 weeks and 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00526461

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Samjot Dhillon, MD Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute Identifier: NCT00526461     History of Changes
Other Study ID Numbers: CDR0000563238
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014

Keywords provided by Roswell Park Cancer Institute:
stage 0 non-small cell lung cancer
adenocarcinoma of the lung
squamous cell lung cancer
large cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms