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

Roswell Park Cancer Institute

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Lung Cancer

Interventions

HPPHDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.