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Photodynamic Therapy in Treating Patients With Lung Cancer

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01668823

First Posted: August 20, 2012

Last Update Posted: July 31, 2014

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.

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Roswell Park Cancer Institute

Purpose

This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with lung cancer. 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, cancer cells are killed.

Condition	Intervention	Phase
Adenocarcinoma of the Lung Large Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Squamous Cell Lung Cancer Stage 0 Non-small Cell Lung Cancer	Drug: HPPH Drug: photodynamic therapy Procedure: therapeutic bronchoscopy	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	A Phase I Study of Light Dose for Photodynamic Therapy(PDT) Using 2-[ 1-hexyloxyethel]-2-devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-small Cell Carcinoma in Situ or Non-small Cell Microinvasive Carcinoma. A Dose Ranging Study

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

Genetic and Rare Diseases Information Center resources: Lung Adenocarcinoma

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:

MTID [ Time Frame: Up to 2 years ]
Defined as the dose at which =< 1 out of 6 patients experiences dose-limiting toxicity.
Systemic toxicity according to NCI Common Toxicity Criteria version 2 [ Time Frame: Up to 6 months ]
PDT-related normal tissue toxicity [ Time Frame: Up to 6 months ]
Assessed by a scale with grades 0-3 being acceptable, grade 4 being unacceptable, and grade 5 being stopping study.

Secondary Outcome Measures:

Objective tumor response [ Time Frame: Up to 6 months ]


Enrollment:	17
Study Start Date:	February 2004
Estimated Study Completion Date:	June 2014
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment (PDT using HPPH) Patients receive HPPH IV over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.	Drug: HPPH Given IV Other Name: Photochlor Drug: photodynamic therapy Undergo photodynamic therapy with HPPH Other Names: Light Infusion Therapy™ PDT therapy, photodynamic Procedure: therapeutic bronchoscopy Undergo therapeutic bronchoscopy for endoscopic debridement

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine maximally tolerated light dose (MTID). Identify systemic and normal tissue toxicity using 2-[hexyloxyethyl)-2-devinyl pyropheophorbide-a (HPPH) for photodynamic therapy in patients with bronchogenic carcinoma-in-situ (CIS) or microinvasive carcinoma.

SECONDARY OBJECTIVES:

I. To study tumor response in patients with bronchogenic carcinoma-in-situ (CIS) or bronchogenic microinvasive carcinoma.

OUTLINE: This is a dose-escalation study.

Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.

After completion of study treatment, patients are followed up at 4-6 weeks, 6 months, and then periodically for at least 2 years.

Eligibility

Information from the National Library of Medicine

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

Criteria

Inclusion Criteria:

Patients with biopsy confirmed carcinoma-in-situ (CIS) or microinvasive lung cancer
Patients may have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma
Patients may have received prior therapy for lung cancer of any type, e.g. chemotherapy, radiation therapy
Patients must have no contraindications for bronchoscopy
Female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal
Patients must have a Karnofsky scale 50 or above (Eastern Cooperative Oncology Group [ECOG] 0-2)
Patients must sign an Informed Consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB)
Patients with underlying lung disease must be judged (by the principal investigator) able to with stand mucous/debris formation at the site of treatment
Definition of CIS or microinvasive lung cancer for this protocol: the lesion will be radiographically occult and not definable by conventional computed tomography (CT) of the chest; the lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on lung imaging fluorescence endoscope (LIFE) bronchoscopy; biopsies of the lesion must indicate no evidence of invasion beyond cartilage on histopathology; the lesion may, however, be invasive through the basement membrane (microinvasive carcinoma)

Exclusion Criteria:

Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
White blood cells (WBC) < 4000
Platelet count < 100,000
Prothrombin time exceeding 1.5 times the upper normal limit
Total serum bilirubin > 3.0 mg/dl
Serum creatinine > 3.0 mg/dl
Alkaline phosphatase (hepatic) or serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
Severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude multiple bronchoscopies or partial central airway obstruction from mucous/debris formation
Any evidence of worsening pulmonary symptoms or COPD exacerbation
Evidence of major pulmonary vessel encasement on CT scan of the chest
Myocardial infarction (Ml) or unstable angina in the previous 6 months

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01668823

Locations


United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263

Sponsors and Collaborators

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Samjot Dhillon	Roswell Park Cancer Institute

More Information


Responsible Party:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT01668823 History of Changes
Other Study ID Numbers:	I 05903 NCI-2010-02114 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted:	August 16, 2012
First Posted:	August 20, 2012
Last Update Posted:	July 31, 2014
Last Verified:	July 2014

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Adenocarcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms	Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type

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