Clinical trial · Interventional
Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPPH | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PDT using HPPH
- description
- 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.
- interventionNames
- Drug: HPPH
Primary outcomes (1)
- measure
- Toxicity as measured by NCI CTC v2.0
- timeFrame
- Daily while in-house, weekly after discharge, at 4-6 weeks and at 6 months
Secondary outcomes (1)
- measure
- Tumor response
- timeFrame
- At 4-6 weeks and 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Biopsy confirmed carcinoma in situ (CIS) or microinvasive bronchogenic non-small cell lung carcinoma * May have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma histology * Stage 0 (CIS or microinvasive) disease, meeting all of the following criteria: * Lesion must be radiographically occult and not definable by conventional CT scan of the chest * Lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on laser-induced fluorescence emission (LIFE) bronchoscopy * Biopsy of the lesion must indicate no evidence of invasion beyond cartilage on histopathology, but may be invasive through the basement membrane (microinvasive carcinoma) * No evidence of major pulmonary vessel encasement on CT scan of the chest PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2 * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 4,000/mm\^3 * Prothrombin time ≤ 1.5 times upper limit of normal (ULN) * Total bilirubin ≤ 3.0 mg/dL * Creatinine ≤ 3.0 mg/dL * Alkaline phosphatase (hepatic) or SGOT ≤ 3 times ULN * No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds * No severe chronic obstructive pulmonary disease, that in the opinion of the investigator, would preclude multiple bronchoscopies or partial central airway obstruction from mucous/debris formation * Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous or debris formation at the site of treatment * No contraindications for bronchoscopy * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy * Prior therapy of any type (e.g., chemotherapy or radiotherapy) allowed for lung cancer
References
Publications (0)
Data not yet available