Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00526461 |
Recruitment Status
:
Completed
First Posted
: September 10, 2007
Last Update Posted
: May 7, 2014
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Tracking Information | ||||
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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 |
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 |
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 |
Tumor response [ Time Frame: At 4-6 weeks and 6 months ] | |||
Original Secondary Outcome Measures ICMJE |
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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Lung Cancer | |||
Intervention ICMJE | Drug: HPPH
IV |
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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 |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
17 | |||
Original Enrollment ICMJE |
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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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 |
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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 |
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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 |