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

Tracking Information
First Submitted Date ICMJE	September 5, 2007
First Posted Date ICMJE	September 10, 2007
Last Update Posted Date	May 7, 2014
Study Start Date ICMJE	February 2004
Actual Primary Completion Date	June 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 3, 2011)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: September 5, 2007)	Toxicity as measured by NCI CTC v2.0
Change History	Complete list of historical versions of study NCT00526461 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 3, 2011)	Tumor response [ Time Frame: At 4-6 weeks and 6 months ]
Original Secondary Outcome Measures ICMJE; (submitted: September 5, 2007)	Tumor response
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer
Official Title ICMJE	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
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.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Lung Cancer
Intervention ICMJE	Drug: HPPH; IV
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 6, 2014)	17
Original Enrollment ICMJE; (submitted: September 5, 2007)	24
Actual Study Completion Date	April 2014
Actual Primary Completion Date	June 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00526461
Other Study ID Numbers ICMJE	CDR0000563238; RPCI-I-05903
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Roswell Park Cancer Institute
Study Sponsor ICMJE	Roswell Park Cancer Institute
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Principal Investigator: Samjot Dhillon, MD Roswell Park Cancer Institute
PRS Account	Roswell Park Cancer Institute
Verification Date	May 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP