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 early stage lung cancer.

Condition	Treatment or Intervention	Phase
Squamous Cell Lung Cancer stage 0 non-small cell lung cancer Adenocarcinoma of the Lung large cell lung cancer	Procedure: laser therapy  Procedure: phototherapy  Procedure: photodynamic therapy  Drug: HPPH	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the systemic and normal tissue toxicity of photodynamic therapy with HPPH in patients with early stage lung cancer. II. Determine, preliminarily, the efficacy of this regimen in these patients.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Histologically confirmed carcinoma in situ or microinvasive lung cancer

• Squamous cell carcinoma
• Adenocarcinoma
• Large cell carcinoma

No tumors that are more than microinvasive

--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 radiotherapy

Surgery: Not specified

Other: Prior therapy for lung cancer allowed

--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/mm3
• Platelet count at least 50,000/mm3

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

New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

Study chairs or principal investigators

Gregory M. Loewen,  Study Chair,  Roswell Park Cancer Institute   

Study ID Numbers:  CDR0000068974; RPCI-RP-0005; NCI-G01-2023
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  October 11, 2001
ClinicalTrials.gov Identifier:  NCT00025571
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08