search
Back to results

Photodynamic Therapy in Treating Patients With Early Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
porfimer sodium
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage 0 esophageal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 22, 2011
Sponsor
Roswell Park Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00002935
Brief Title
Photodynamic Therapy in Treating Patients With Early Esophageal Cancer
Official Title
A Phase II Study of the Safety and Efficacy of Photodynamic Therapy in Carcinoma in Situ of the Esophagus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 1995 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
stage 0 esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
porfimer sodium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hector R. Nava, MD, FACS
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Photodynamic Therapy in Treating Patients With Early Esophageal Cancer

We'll reach out to this number within 24 hrs