Lung Cancer Clinical Trial

Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer

Summary

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed.

PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with stage 0 non-small cell lung cancer.

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Full Description

OBJECTIVES:

Primary

To determine the maximally tolerated light dose (MTID) in patients with bronchogenic carcinoma in situ (CIS) or bronchogenic microinvasive carcinoma.
To identify the systemic and normal tissue toxicity resulting from photodynamic therapy using HPPH in these patients.

Secondary

To study tumor response in these patients.

OUTLINE: Patients receive HPPH IV over 1 hour on day 1. Approximately 2 days later, patients undergo photodynamic therapy (PDT) using laser light 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 at that time.

After completion of study treatment, patients are followed at 4-6 weeks, 6 months, and periodically thereafter.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Biopsy confirmed carcinoma in situ (CIS) or microinvasive bronchogenic non-small cell lung carcinoma

May have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma histology

Stage 0 (CIS or microinvasive) disease, meeting all of the following criteria:

Lesion must be radiographically occult and not definable by conventional CT scan of the chest
Lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on laser-induced fluorescence emission (LIFE) bronchoscopy
Biopsy of the lesion must indicate no evidence of invasion beyond cartilage on histopathology, but may be invasive through the basement membrane (microinvasive carcinoma)
No evidence of major pulmonary vessel encasement on CT scan of the chest

PATIENT CHARACTERISTICS:

Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
Platelet count ≥ 100,000/mm^3
WBC ≥ 4,000/mm^3
Prothrombin time ≤ 1.5 times upper limit of normal (ULN)
Total bilirubin ≤ 3.0 mg/dL
Creatinine ≤ 3.0 mg/dL
Alkaline phosphatase (hepatic) or SGOT ≤ 3 times ULN
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 or partial central airway obstruction from mucous/debris formation
Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous or debris formation at the site of treatment
No contraindications for bronchoscopy
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
Prior therapy of any type (e.g., chemotherapy or radiotherapy) allowed for lung cancer

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

17

Study ID:

NCT00526461

Recruitment Status:

Completed

Sponsor:

Roswell Park Cancer Institute

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

17

Study ID:

NCT00526461

Recruitment Status:

Completed

Sponsor:


Roswell Park Cancer Institute

How clear is this clinincal trial information?

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