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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00025571

Enrollment

Unknown

Registered

2003-06-25

Start date

2001-06-30

Completion date

2004-10-31

Last updated

2011-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

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

Brief summary

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

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.

Interventions

DRUGHPPH

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026