Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors

OBJECTIVES:

• Determine, preliminarily, the safety of HPPH in patients with obstructive esophageal tumors undergoing photodynamic therapy.
• Determine, preliminarily, tumor response in patients treated with this drug.
• Determine the length of time for cutaneous photosensitivity at the various drug doses in these patients.
• Determine plasma clearance rates for this drug in these patients.

OUTLINE: This is a dose-escalation study.

• Phase I: Patients receive HPPH IV over 1 hour on day 1. Patients then undergo laser light therapy on day 2.

Cohorts of 3 patients receive escalating doses of HPPH and a single light dose until the optimal dose is determined. The optimal dose is defined as the minimum dose producing efficacy without unacceptable toxicity.

• Phase II: Patients receive treatment as in phase I at the optimal dose. Patients are followed monthly for 6-24 months.

PROJECTED ACCRUAL: A total of 9-14 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed esophageal cancer

• Stages T1-T3, any N, any M
• Tumor partially or completely obstructing the esophagus
• Primary or recurrent tumor meeting 1 of the following criteria for treatment:

• Patient is too debilitated for or refused conventional therapy
• Recurred after or failed to respond to chemotherapy, radiotherapy, or surgery
• Deemed most appropriately treated by photodynamic therapy (PDT) in the opinion of the physician
• Persistent symptomatic disease required in patients who received prior radiotherapy, chemotherapy, or PDT with photofrin or HPPH

• Prior PDT with HPPH allowed only if tumor is evident outside of the original treatment site
• No tracheal or bronchial involvement by bronchoscopy
• No T4 lesions involving the aorta, lung, or pericardium by CT scan, MRI, or endoscopic ultrasonography

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Not specified

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

Other

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• No contraindications to endoscopy
• No porphyria
• No hypersensitivity to porphyrins

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy
• No concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• More than 4 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery

• Not specified

Other

• No concurrent photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylureas, hypoglycemic agents, thiazide diuretics, and griseofulvin)