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A Phase II Study of the Safety and Efficacy of Photodynamic Therapy in Carcinoma in Situ of the Esophagus


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

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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 InstituteBuffalo, New York  14263