Photodynamic Therapy in Treating Patients With Lung Cancer
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ClinicalTrials.gov Identifier: NCT01668823 |
Recruitment Status
:
Completed
First Posted
: August 20, 2012
Last Update Posted
: July 31, 2014
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Condition or disease | Intervention/treatment | 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 |
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.
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 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 |
Study Start Date : | February 2004 |
Actual Primary Completion Date : | June 2013 |
Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: HPPH
Given IV
Other Name: Photochlor
Drug: photodynamic therapy
Undergo photodynamic therapy with HPPH
Other Names:
Procedure: therapeutic bronchoscopy
Undergo therapeutic bronchoscopy for endoscopic debridement
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- 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.
- Objective tumor response [ Time Frame: Up to 6 months ]

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

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
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263 |
Principal Investigator: | Samjot Dhillon | Roswell Park Cancer Institute |
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 Posted: | August 20, 2012 Key Record Dates |
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 |