Photodynamic Therapy Using HPPH in Treating Patients With Advanced Non-Small Cell Lung Cancer That Blocks the Air Passages - Non Small Cell Lung Cancer Clinical Trials

Photodynamic Therapy Using HPPH in Treating Patients With Advanced Non-Small Cell Lung Cancer That Blocks the Air Passages
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsors and Collaborators: Roswell Park Cancer Institute
National Cancer Institute (NCI)

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00528775

Purpose
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for advanced non-small cell lung cancer that blocks the air passages.

PURPOSE: This phase II trial is studying how well photodynamic therapy using HPPH works in treating patients with advanced non-small cell lung cancer that blocks the air passages.

Condition Intervention Phase
Lung Cancer
Drug: HPPH
Procedure: endoscopic procedure
Phase II

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Photodynamic Therapy (PDT) Using 2-[1-Hexyloxyethyl]-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Advanced Obstructing Endobronchial Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
Tumor response [ Designated as safety issue: No ]

Secondary Outcome Measures:
Palliation of symptoms as assessed by the pulmonary symptom scale [ Designated as safety issue: No ]

Photosensitizer (HPPH) concentration in tumor [ Designated as safety issue: No ]

STAT3 cross-links as assessed by western blotting [ Designated as safety issue: No ]

Inflammation and apoptosis as assessed by immunohistochemistry [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2007
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:

Primary

To determine the efficacy of photodynamic therapy (PDT) using HPPH in patients with advanced obstructing endobronchial non-small cell lung cancer.
Secondary

To determine palliation of symptoms in patients treated with this regimen.
To determine the amount of HPPH taken up by the obstructing endobronchial tumors in these patients.
To determine the extent of STAT3 cross-links, which are molecular markers of immediate PDT reaction, in the obstructing tumors of these patients before and after PDT treatment.
To determine inflammation and apoptosis in the obstructing bronchial tumors of these patients before and after PDT treatment.
OUTLINE: Patients receive HPPH IV over 1 hour on day 1. On day 3, patients undergo photodynamic therapy (PDT) comprising laser light delivered by flexible, fiberoptic fibers 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.

Patients may undergo tumor biopsies periodically during study for optional biomarker/correlative studies. Tumor tissue samples are analyzed for STAT3 cross-links by western blotting; apoptosis and inflammation biomarkers by immunohistochemistry, TUNEL, and other immunological laboratory methods; and tumor concentrations of HPPH by fluorescence emission spectroscopy.

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

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Biopsy confirmed advanced obstructing endobronchial non-small cell lung cancer

May have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma histology
Ineligible for or refused surgical resection
Local endobronchial recurrence after prior surgical resection, radiotherapy, or chemotherapy allowed
No evidence of tumor encasement of major pulmonary vessels on CT scan of the chest
PATIENT CHARACTERISTICS:

Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
WBC ≥ 4,000/mm³
Platelet count ≥ 100,000/mm³
Prothrombin time < 1.5 times upper limit of normal (ULN)
Total bilirubin ≤ 2.0 mg/dL
Creatinine ≤ 2.0 mg/dL
Alkaline phosphatase (hepatic) ≤ 3 times ULN
SGOT ≤ 3 times ULN
No contraindications for bronchoscopy
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after the completion of study treatment
Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous/debris formation at the site of treatment
Patients who cannot breathe due to complete upper airway obstruction and who need emergency treatment to open the airway are not eligible
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
No partial central airway obstruction from mucous/debris formation
No high-grade upper airway obstruction of the trachea
PRIOR CONCURRENT THERAPY:

Any type of prior therapy (e.g., chemotherapy or radiotherapy) for lung cancer allowed
At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528775

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724

Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Todd L. Demmy, MD Roswell Park Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Responsible Party: Roswell Park Cancer Institute ( Todd L. Demmy )
Study ID Numbers: CDR0000563948, RPCI-I-98707
Study First Received: September 10, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00528775 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the lung
large cell lung cancer
squamous cell lung cancer
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma of lung
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 10, 2009

Back to top of Main Content

U.S. National Library of Medicine, Contact Help Desk
U.S. National Institutes of Health, U.S. Department of Health & Human Services,
USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act