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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Toxicity as measured by NCI CTC v2.0
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: HPPH (Drug)
Outcomes
Primary Outcomes
Toxicity as measured by NCI CTC v2.0
Time Frame: Daily while in-house, weekly after discharge, at 4-6 weeks and at 6 months
Secondary Outcomes
- Tumor response(At 4-6 weeks and 6 months)