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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00528775
• Other study ID #: CDR0000563948
• Secondary ID: RPCI-I-98707
• Status: Terminated
• Phase: Phase 2
• First received: September 10, 2007
• Last updated: May 9, 2014
• Start date: August 2007
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 2014
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• HPPH
4 mg/m2 IV

Procedure:
• endoscopic procedure
Treatment with 150 joules from laser

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Response		6 months	No
Secondary	Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale		2 months	No
Secondary	Photosensitizer (HPPH) Concentration in Tumor		2 months	No
Secondary	STAT3 Cross-links as Assessed by Western Blotting		2 months	No
Secondary	Inflammation and Apoptosis as Assessed by Immunohistochemistry		2 months	No