Photodynamic Therapy With HPPH in Treating Patients With Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Determine the systemic and normal tissue toxicity of photodynamic therapy with HPPH in patients with early stage or centrally obstructing non-small cell lung cancer. Determine, preliminarily, the efficacy of this regimen in these patients. OUTLINE: This is a dose-escalation study of HPPH. Patients receive HPPH IV over 1 hour on day 1. Patients undergo laser light therapy via bronchoscopy on day 3. Cohorts of 3-6 patients receive escalating doses of HPPH until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for at least 6 months. PROJECTED ACCRUAL: Approximately 15-17 patients will be accrued for this study within 2 years.

Official Title
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A Phase I Study of Photodynamic Therapy (PDT) Using 2-(1-hexyloxyethyl)-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Early Stage Lung Cancer - A Dose Ranging Study

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: HPPH


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed microinvasive or centrally obstructing non-small cell lung cancer Squamous cell carcinoma Adenocarcinoma Large cell carcinoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% OR ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 2,000/mm^3 Platelet count at least 50,000/mm^3 Hepatic: Bilirubin no greater than 3.0 mg/dL Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) SGOT no greater than 3 times ULN PT no greater than 1.5 times ULN Renal: Creatinine no greater than 3.0 mg/dL Pulmonary: No severe chronic obstructive pulmonary disease that would preclude study Other: Not pregnant Fertile patients must use effective contraception No contraindications to bronchoscopy No porphyria No hypersensitivity to porphyrin or porphyrin-like compounds PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy for lung cancer allowed Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: Prior endocrine therapy for lung cancer allowed Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent external beam radiotherapy Surgery: No concurrent surgery Other: Prior therapy for lung cancer allowed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HPPH|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, stage I non-small cell lung cancer, stage II non-small cell lung cancer