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

Lung Cancer Clinical Trial

Official title:

A Phase I Study Light Dose for Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-Small Cell Carcinoma in Situ or Non-Small Cell Microinvasive Bronchogenic Carcinoma: A Dose Ranging Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526461
• Other study ID #: CDR0000563238
• Secondary ID: RPCI-I-05903
• Status: Completed
• Phase: Phase 1
• Start date: February 2004
• Est. completion date: April 2014

Study information

• Verified date: August 2023
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• HPPH
IV

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity as measured by NCI CTC v2.0		Daily while in-house, weekly after discharge, at 4-6 weeks and at 6 months
Secondary	Tumor response		At 4-6 weeks and 6 months