Photodynamic Therapy in Treating Patients With Lung Cancer

Recurrent Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668823
• Other study ID #: I 05903
• Secondary ID: NCI-2010-02114
• Status: Completed
• Phase: Phase 1
• First received: August 16, 2012
• Last updated: July 30, 2014
• Start date: February 2004
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Lung
• Carcinoma, Non-Small-Cell Lung
• Large Cell Lung Cancer
• Lung Neoplasms
• Recurrent Non-small Cell Lung Cancer
• Squamous Cell Lung Cancer
• Stage 0 Non-small Cell Lung Cancer

Intervention

Drug:
• HPPH
Given IV
• photodynamic therapy
Undergo photodynamic therapy with HPPH

Procedure:
• therapeutic bronchoscopy
Undergo therapeutic bronchoscopy for endoscopic debridement

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTID	Defined as the dose at which =< 1 out of 6 patients experiences dose-limiting toxicity.	Up to 2 years	Yes
Primary	Systemic toxicity according to NCI Common Toxicity Criteria version 2		Up to 6 months	Yes
Primary	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	Yes
Secondary	Objective tumor response		Up to 6 months	No