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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00528775

Enrollment

Registered

2007-09-12

Start date

2007-08-31

Completion date

2014-03-31

Last updated

2014-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGHPPH

4 mg/m2 IV

PROCEDUREendoscopic procedure

Treatment with 150 joules from laser

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Tumor Response	6 months

Secondary

Measure	Time frame
Inflammation and Apoptosis as Assessed by Immunohistochemistry	2 months
Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale	2 months
Photosensitizer (HPPH) Concentration in Tumor	2 months
STAT3 Cross-links as Assessed by Western Blotting	2 months

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. HPPH: 4 mg/m2 IV endoscopic procedure: Treatment with 150 joules from laser	6
Total	6

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Other not specified	1

Baseline characteristics

Characteristic	HPPH
Age, Continuous	64 years STANDARD_DEVIATION 12.52
Sex: Female, Male Female	3 Participants
Sex: Female, Male Male	3 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	4 / 6
serious Total, serious adverse events	5 / 6