Status:
COMPLETED
Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
BTG International Inc.
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to see if Therasphere will be a better way to treat cholangiocarcinoma. The investigators want to find out what effects, good and/or bad, this treatment will have on the p...
Detailed Description
The goal of treatment with TheraSphere is to allow a large dose of radiation to be delivered directly to the tumor with less risk of toxic effects from radiation to other parts of the body or to healt...
Eligibility Criteria
Inclusion
- Patients must have newly diagnosed or recurrent (post surgery) histologically or cytologically proven cholangiocarcinoma.
- Patients can have solitary, multifocal unilobar, or bilobar disease without evidence of extrahepatic involvement. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>10 mm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI).
- Age \>18 years
- Life expectancy of greater than 3 months based on physician judgment
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 (Karnofsky 50%)
- No prior chemotherapy or radiation treatment for cholangiocarcinoma
- Childs-Pugh score A or Childs-Pugh score B without portal vein thrombus
- Lung shunting that predicts lung dose to be \<30 Gy in a single treatment
- The effects of TheraSpheres on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radioactive spheres are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document
- Adequate baseline hematopoietic function:
- total white blood cell count equal to or greater than 3,000/mm³
- absolute granulocyte count greater than 1,500/mm³
- platelet count equal to or greater than 100,000/mm³
- Hemoglobin \>8.0
Exclusion
- Patients receiving any other investigational agents
- Patients with extrahepatic disease
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because TheraSpheres are radioactive and radiation is a known agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TheraSpheres, breastfeeding should be discontinued if the mother is treated with TheraSpheres.
- Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. In addition, antiretrovirals are known radiation sensitizers and could dramatically increase the risk of fulminant hepatic failure. Therefore, HIV-positive patients are excluded from the study because of possible lethal side effects.
- Bulk disease (tumor volume \> 70% of the target liver volume, or tumor nodules too numerous to count)
- Aspartic transaminase (AST) or alanine transaminase (ALT) \> 5 times upper limit of normal (ULN)
- Bilirubin \> 2 mg/dL
- Child-Pugh C Liver Cirrhosis
- Tumor volume \> 50% combined with an albumin \< 3 g/dL
- Complete occlusion of main portal vein causing portal hypertension
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01253148
Start Date
January 1 2011
End Date
August 1 2015
Last Update
March 22 2017
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612