Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

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/II trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have obstructive esophageal tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute

Criteria

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)