Overview

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

Status:
Terminated
Trial end date:
2014-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Roswell Park Cancer Institute
Collaborator:
National Cancer Institute (NCI)
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