Clinical trial NCT00528775: Photodynamic Therapy Using HPPH in Treating Patients With Advanced Non-Small Cell Lung Cancer That Blocks the Air Passages
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: 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
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-09-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Tumor Response
timeFrame: 6 months
Secondary outcomes:
measure: Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale
timeFrame: 2 months
measure: Photosensitizer (HPPH) Concentration in Tumor
timeFrame: 2 months
measure: STAT3 Cross-links as Assessed by Western Blotting
timeFrame: 2 months
measure: Inflammation and Apoptosis as Assessed by Immunohistochemistry
timeFrame: 2 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Todd L. Demmy, MD
role: PRINCIPAL_INVESTIGATOR
References: