Esophageal Cancer Clinical Trial
Official title:
A Phase II Study of the Safety and Efficacy of Photodynamic Therapy in Carcinoma in Situ of the Esophagus
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive
to light to kill tumor cells. This may be an effective treatment for esophageal cancer.
PURPOSE: Phase II trial to study the effectiveness of photodynamic therapy in treating
patients with Barrett's esophagus who have in situ esophageal cancer.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2007 |
Est. primary completion date | August 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: Histologically confirmed primary, stage 0 carcinoma in situ (CIS)
in conjunction with Barrett's esophagus or severe dysplasia in Barrett's esophagus who are
medically unsuitable for or have refused surgery Previously biopsied Barrett's mucosa with
areas of severe dysplasia and/or CIS PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky greater than 50% Life expectancy: Not specified Hematopoietic: WBC at least 2,000/mm3 Platelet count at least 50,000/mm3 Hepatic: No porphyria or hypersensitivity to porphyrins Bilirubin no greater than 3.0 mg/dL Alkaline phosphatase no greater than 3 times ULN SGOT no greater than 3 times ULN PT no greater than 1.5 times the upper limit of normal (ULN) Renal: Creatinine no greater than 3.0 mg/dL Other: No contraindication to endoscopy Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy At least 1 month since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiation therapy No concurrent laser therapy At least 1 month since prior radiation therapy At least 1 month since prior laser therapy Surgery: Not specified |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute |
United States,
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