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Photodynamic Therapy in Treating Patients With Early Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002935
Recruitment Status : Completed
First Posted : October 22, 2003
Last Update Posted : December 23, 2011
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: porfimer sodium Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of the Safety and Efficacy of Photodynamic Therapy in Carcinoma in Situ of the Esophagus
Study Start Date : October 1995
Actual Primary Completion Date : August 2006
Actual Study Completion Date : September 2007

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002935


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
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Study Chair: Hector R. Nava, MD, FACS Roswell Park Cancer Institute
More Information
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00002935    
Other Study ID Numbers: DS 93-23
RPCI-DS-93-23
First Posted: October 22, 2003    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011
Keywords provided by Roswell Park Cancer Institute:
stage 0 esophageal cancer
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
 Esophageal Diseases
Gastrointestinal Diseases
Dihematoporphyrin Ether
Trioxsalen
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents