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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- MTID
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: HPPH (Drug)
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.
Intervention: photodynamic therapy (Drug)
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.
Intervention: therapeutic bronchoscopy (Procedure)
Outcomes
Primary Outcomes
MTID
Time Frame: Up to 2 years
Defined as the dose at which =\< 1 out of 6 patients experiences dose-limiting toxicity.
Systemic toxicity according to NCI Common Toxicity Criteria version 2
Time Frame: Up to 6 months
PDT-related normal tissue toxicity
Time Frame: Up to 6 months
Assessed by a scale with grades 0-3 being acceptable, grade 4 being unacceptable, and grade 5 being stopping study.
Secondary Outcomes
- Objective tumor response(Up to 6 months)