Lung Cancer Clinical Trial
Photodynamic Therapy With HPPH in Treating Patients With Non-Small Cell Lung Cancer
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Buffalo New York, 14263, United States
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