Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active 18 and over NCI RPCI-I-05903 I 05903, NCT00526461

Objectives

Primary

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

Secondary

1. To study tumor response in these patients.

Entry 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

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

Patient Characteristics:

• Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
• Platelet count ≥ 100,000/mm³
• WBC ≥ 4,000/mm³
• 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

Expected Enrollment

Outcomes

Toxicity as measured by NCI CTC v2.0

Tumor response

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Todd Demmy, MD, Principal investigator		Ph: 716-845-5873; 800-685-6825

U.S.A.
New York
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724

Registry Information
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
Trial Start Date		2004-02-25
Trial Completion Date		2012-07-03 (estimated)
Registered in ClinicalTrials.gov		NCT00526461
Date Submitted to PDQ		2007-08-14
Information Last Verified		2008-04-20
NCI Grant/Contract Number		CA16056