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

NCT ID: NCT00528775

Last Updated: 2014-06-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2014-03-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HPPH

Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.

Group Type: EXPERIMENTAL

HPPH

Intervention Type: DRUG

4 mg/m2 IV

endoscopic procedure

Intervention Type: PROCEDURE

Treatment with 150 joules from laser

Interventions

HPPH

4 mg/m2 IV

Intervention Type: DRUG

endoscopic procedure

Treatment with 150 joules from laser

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd L. Demmy, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-I-98707

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000563948

Identifier Type: -

Identifier Source: org_study_id