Clinical trial · Interventional
Photodynamic Therapy in Treating Patients With Lung Cancer
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
NCT01668823CI-TRIAL-00015271completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Lung | Lung Adenocarcinoma | ALIAS | 0.90 |
| Large Cell Lung Cancer | Lung Large Cell Carcinoma | ALIAS | 0.90 |
| Recurrent Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Squamous Cell Lung Cancer | Lung Squamous Cell Carcinoma | ALIAS | 0.90 |
| Stage 0 Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPPH | Drug | — | UNRESOLVED |
| photodynamic therapy | Drug | — | UNRESOLVED |
| therapeutic bronchoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (PDT using HPPH)
- description
- 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.
- interventionNames
- Drug: HPPH
- Drug: photodynamic therapy
- Procedure: therapeutic bronchoscopy
Primary outcomes (3)
- measure
- MTID
- timeFrame
- Up to 2 years
- description
- Defined as the dose at which =\< 1 out of 6 patients experiences dose-limiting toxicity.
- measure
- Systemic toxicity according to NCI Common Toxicity Criteria version 2
- timeFrame
- Up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.