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| Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002935 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: porfimer sodium |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of the Safety and Efficacy of Photodynamic Therapy in Carcinoma in Situ of the Esophagus |
| Estimated Enrollment: | 20 |
| Study Start Date: | October 1995 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Study Chair: | Hector R. Nava, MD, FACS | Roswell Park Cancer Institute |
More Information
| Study ID Numbers: | CDR0000065371, RPCI-DS-93-23, NCI-G97-1138 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002935 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage 0 esophageal cancer |
|
Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Esophageal Cancer Carcinoma Photosensitizing Agents Digestive System Diseases Radiation-Sensitizing Agents |
Esophageal Disorder Dihematoporphyrin Ether Carcinoma in Situ Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Trioxsalen |
|
Digestive System Neoplasms Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Physiological Effects of Drugs Pharmacologic Actions Photosensitizing Agents Neoplasms Digestive System Diseases |
Neoplasms by Site Radiation-Sensitizing Agents Dihematoporphyrin Ether Head and Neck Neoplasms Therapeutic Uses Gastrointestinal Neoplasms Esophageal Diseases Trioxsalen Dermatologic Agents |
