A Phase II Study of the Safety and Efficacy of Photodynamic Therapy in Carcinoma in Situ of the Esophagus
18 Years
N/A
Both
Esophageal Cancer
Trial Information
A Phase II Study of the Safety and Efficacy of Photodynamic Therapy in Carcinoma in Situ of the Esophagus
OBJECTIVES: I. Evaluate the efficacy of photodynamic therapy (PDT) using porfimer sodium
(Photofrin) and controlled uniform laser light in patients with carcinoma in situ in
Barrett's esophagus or severe dysplasia in Barrett's esophagus. II. Evaluate the safety of
the treatment on this patient.
OUTLINE: This is a noncomparative study. PDT consists of IV porfimer sodium followed 40-50
hours later by laser red light delivered by optic fibers passed through the biopsy channel
of an endoscope. Retreatment, if necessary, consists of up to 3 injections at least 30 days
apart and up to 6 laser light treatments, with a maximum of 2 following each injection.
Patients are followed monthly for 4 months, and then periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Hector R. Nava, MD, FACS
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
DS 93-23
NCT ID:
NCT00002935
Start Date:
October 1995
Completion Date:
September 2007
Related Keywords:
- Esophageal Cancer
- stage 0 esophageal cancer
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
