Photodynamic Therapy in Treating Patients With Lung Cancer

A Phase I Study of Light Dose for Photodynamic Therapy(PDT) Using 2-[ 1-hexyloxyethel]-2-devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-small Cell Carcinoma in Situ or Non-small Cell Microinvasive Carcinoma. A Dose Ranging Study

This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with lung cancer. 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, cancer cells are killed.

Study Overview

• Status: Completed
• Conditions: Recurrent Non-small Cell Lung Cancer; Stage 0 Non-small Cell Lung Cancer; Squamous Cell Lung Cancer; Adenocarcinoma of the Lung; Large Cell Lung Cancer
• Intervention / Treatment: Drug: HPPH; Drug: photodynamic therapy; Procedure: therapeutic bronchoscopy

Detailed Description

PRIMARY OBJECTIVES:

I. To determine maximally tolerated light dose (MTID). Identify systemic and normal tissue toxicity using 2-[hexyloxyethyl)-2-devinyl pyropheophorbide-a (HPPH) for photodynamic therapy in patients with bronchogenic carcinoma-in-situ (CIS) or microinvasive carcinoma.

SECONDARY OBJECTIVES:

I. To study tumor response in patients with bronchogenic carcinoma-in-situ (CIS) or bronchogenic microinvasive carcinoma.

OUTLINE: This is a dose-escalation study.

Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.

After completion of study treatment, patients are followed up at 4-6 weeks, 6 months, and then periodically for at least 2 years.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with biopsy confirmed carcinoma-in-situ (CIS) or microinvasive lung cancer
• Patients may have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma
• Patients may have received prior therapy for lung cancer of any type, e.g. chemotherapy, radiation therapy
• Patients must have no contraindications for bronchoscopy
• Female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal
• Patients must have a Karnofsky scale 50 or above (Eastern Cooperative Oncology Group [ECOG] 0-2)
• Patients must sign an Informed Consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB)
• Patients with underlying lung disease must be judged (by the principal investigator) able to with stand mucous/debris formation at the site of treatment
• Definition of CIS or microinvasive lung cancer for this protocol: the lesion will be radiographically occult and not definable by conventional computed tomography (CT) of the chest; the lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on lung imaging fluorescence endoscope (LIFE) bronchoscopy; biopsies of the lesion must indicate no evidence of invasion beyond cartilage on histopathology; the lesion may, however, be invasive through the basement membrane (microinvasive carcinoma)

Exclusion Criteria:

• Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
• White blood cells (WBC) < 4000
• Platelet count < 100,000
• Prothrombin time exceeding 1.5 times the upper normal limit
• Total serum bilirubin > 3.0 mg/dl
• Serum creatinine > 3.0 mg/dl
• Alkaline phosphatase (hepatic) or serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
• Severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude multiple bronchoscopies or partial central airway obstruction from mucous/debris formation
• Any evidence of worsening pulmonary symptoms or COPD exacerbation
• Evidence of major pulmonary vessel encasement on CT scan of the chest
• Myocardial infarction (Ml) or unstable angina in the previous 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (PDT using HPPH); Patients receive HPPH IV over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5.	Drug: HPPH; Given IV; Other Names: Photochlor; Drug: photodynamic therapy; Undergo photodynamic therapy with HPPH; Other Names: PDT; Light Infusion Therapy™; therapy, photodynamic; Procedure: therapeutic bronchoscopy; Undergo therapeutic bronchoscopy for endoscopic debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MTID	Defined as the dose at which =< 1 out of 6 patients experiences dose-limiting toxicity.	Up to 2 years
Systemic toxicity according to NCI Common Toxicity Criteria version 2		Up to 6 months
PDT-related normal tissue toxicity	Assessed by a scale with grades 0-3 being acceptable, grade 4 being unacceptable, and grade 5 being stopping study.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective tumor response	Up to 6 months

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Samjot Dhillon, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): June 1, 2013
• Study Completion: June 1, 2014

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (Estimate): August 20, 2012

Study Record Updates

• Last Update Posted (Estimate): July 31, 2014
• Last Update Submitted That Met QC Criteria: July 30, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung
• Other Study ID Numbers: I 05903; NCI-2010-02114 (Registry Identifier: CTRP (Clinical Trial Reporting Program))