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

• Sponsor: Roswell Park Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00526461
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 17
• Location: 1
• Arm: 1
• Duration (Months): 122
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: HPPH	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PDT using HPPH Patients receive HPPH IV over 1 hour on day 1. Patients then receive photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.	Drug: HPPH; IV

Outcome Measures

Primary Outcome Measures

1. Toxicity as measured by NCI CTC v2.0 [Daily while in-house, weekly after discharge, at 4-6 weeks and at 6 months]

Secondary Outcome Measures

1. Tumor response [At 4-6 weeks and 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001

Sponsors and Collaborators

• Roswell Park Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Samjot Dhillon, MD, Roswell Park Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT00526461
• Other Study ID Numbers: CDR0000563238; RPCI-I-05903
• First Posted: Sep 10, 2007
• Last Update Posted: May 7, 2014
• Last Verified: May 1, 2014

• Keywords provided by Roswell Park Cancer Institute: stage 0 non-small cell lung cancer; adenocarcinoma of the lung; squamous cell lung cancer; large cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of May 7, 2014