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Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003923
  Purpose

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.


Condition Intervention Phase
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Liver Cancer
Pancreatic Cancer
Drug: porfimer sodium
Phase II

Genetics Home Reference related topics:   Bile Duct Diseases   Cancer   Digestive Diseases  

MedlinePlus related topics:   Cancer   Liver Cancer   Pancreatic Cancer  

ChemIDplus related topics:   Porfimer sodium   Dihematoporphyrin ether   Trioxsalen   Pancrelipase   Ultrase   Hematoporphyrin derivative  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of Photodynamic Therapy With PHOTOFRIN (Porfimer Sodium) for Injection in Patients With Malignant Bile Duct Obstruction

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   30
Study Start Date:   March 1999

Detailed Description:

OBJECTIVES: I. Determine the safety and efficacy of photodynamic therapy using porfimer sodium in patients with unresectable malignant bile duct obstruction.

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003923

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Hans Gerdes, MD     Memorial Sloan-Kettering Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067110, MSKCC-99015, NCI-G99-1525
First Received:   November 1, 1999
Last Updated:   June 21, 2008
ClinicalTrials.gov Identifier:   NCT00003923
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I pancreatic cancer  
stage II pancreatic cancer  
stage III pancreatic cancer  
stage IV pancreatic cancer  
recurrent pancreatic cancer  
unresectable gallbladder cancer  
recurrent gallbladder cancer
unresectable extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer
cholangiocarcinoma of the gallbladder
cholangiocarcinoma of the extrahepatic bile duct
adult primary cholangiocellular carcinoma

Study placed in the following topic categories:
Gallbladder Diseases
Liver Diseases
Cholestasis
Pancreatic Neoplasms
Liver neoplasms
Pancrelipase
Liver Neoplasms
Biliary Tract Diseases
Hematoporphyrin Derivative
Trioxsalen
Endocrine Gland Neoplasms
Hepatocellular carcinoma
Bile duct cancer, extrahepatic
Cholangiocarcinoma
Digestive System Neoplasms
Biliary Tract Neoplasms
Recurrence
Carcinoma
Gall bladder cancer
Bile Duct Diseases

Additional relevant MeSH terms:
Photosensitizing Agents
Neoplasms
Digestive System Diseases
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Endocrine System Diseases
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008




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