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Home > "P" Clinical Trials Conditions > Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas  Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas
Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas
For Condition: Pancreatic Cancer,Gallbladder Cancer,Bile Duct Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for cancer of the bile duct, gallbladder, or pancreas. PURPOSE: Phase II trial to determine the effectiveness of photodynamic therapy in treating patients who have cancer of the bile duct, gallbladder, or pancreas.
Details: OBJECTIVES: I. Determine the safety and efficacy of photodynamic therapy using porfimer sodium in patients with unresectable malignant bile duct obstruction. PROTOCOL OUTLINE: Patients are stratified according to tumor location (proximal vs distal). Patients receive porfimer sodium IV over 3-5 minutes on day 1, followed by percutaneous or endoscopic laser light treatment on day 3. Patients achieving partial response or complete response accompanied by an increase in total bilirubin or cholangitis may repeat treatment for a maximum of 3 courses. Patients are followed weekly for 1 month, and then monthly for 1 year. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven malignant bile duct obstruction with obstructive jaundice; Primary carcinoma of bile duct, gallbladder, or pancreas OR Metastatic bile duct disease; Successful insertion of a percutaneous drain or endoscopic stent; Unresectable disease OR Resectable disease but refusal of surgery - Prior biliary plastic or metallic stent allowed, if requiring stent replacement due to recurrent jaundice or routine plastic stent change - No erosion of biliary tumors into major blood vessels - No evidence of bile duct perforation --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No concurrent radiotherapy or brachytherapy to the abdomen - Surgery: See Disease Characteristics - Other: No other prior or concurrent experimental or investigational drugs --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 50-100% - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin at least 2 mg/dL - Renal: Not specified - Other: No history of allergies or hypersensitivity to porphyrins; No porphyria; No cholangitis or pancreatitis
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HansGerdes, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067110; MSKCC-99015,NCI-G99-1525
Study Start Date: March 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003923
Other Pancreatic Cancer Studies:
1. Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas
Related Studies:
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Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas
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