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
|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|
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.
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)|
|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|
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.
Other Name: Photochlor
Drug: photodynamic therapy
Undergo photodynamic therapy with HPPH
Procedure: therapeutic bronchoscopy
Undergo therapeutic bronchoscopy for endoscopic debridement
- 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 ]
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|