Clinical trial NCT01668823: Photodynamic Therapy in Treating Patients With Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adenocarcinoma of the Lung
Large Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Squamous Cell Lung Cancer
Stage 0 Non-small Cell Lung Cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-08-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: MTID
timeFrame: Up to 2 years
measure: Systemic toxicity according to NCI Common Toxicity Criteria version 2
timeFrame: Up to 6 months
measure: PDT-related normal tissue toxicity
timeFrame: Up to 6 months
Secondary outcomes:
measure: Objective tumor response
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Samjot Dhillon
role: PRINCIPAL_INVESTIGATOR
References: