Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma

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Brief Title

Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma

Official Title

Phase II Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres As First-Line Treatment For Cholangiocarcinoma

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 patient and their cancer.
    

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 healthy liver tissue when compared with currently available treatments.

      The standard treatment for cholangiocarcinoma is surgery (if possible), external beam
      radiation therapy and/or chemotherapy. External beam radiation therapy to the liver may
      reduce symptoms, but only 20% of patients experience significant tumor shrinkage.
      Chemotherapy has response rates ranging from 6-19%. More recently, a new approach has been
      developed, called TheraSphere. Based on the results of earlier studies with TheraSphere, the
      study doctors at Moffitt feel this is a reasonable alternative to the standard treatment for
      this disease.

      TheraSphere has restricted approval from the United States Food and Drug Administration (FDA)
      for the treatment of hepatocellular liver cancer; but it has not yet been approved for the
      treatment of cholangiocarcinoma. TheraSphere is a medical device containing yttrium-90
      (Y-90), a radioactive material that has been used previously in the treatment of liver
      tumors. Y-90 is incorporated into very tiny glass beads called microspheres and is injected
      into the liver through the blood vessels supplying the liver.
    


Study Type

Interventional


Primary Outcome

Median Progression Free Survival (PFS)

Secondary Outcome

 Median Overall Survival (OS)

Condition

Cholangiocarcinoma

Intervention

TheraSphere® Yttrium-90 (Y-90) Microspheres

Study Arms / Comparison Groups

 Arterial Injection of 90-Y Microspheres
Description:  Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

25

Start Date

January 2011

Completion Date

August 2015

Primary Completion Date

August 2015

Eligibility Criteria

        Inclusion Criteria:

          -  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 Criteria:

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sarah Hoffe, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01253148

Organization ID

MCC-16236

Secondary IDs

NCI-2011-00794

Responsible Party

Sponsor

Study Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

 BTG International Inc.

Study Sponsor

Sarah Hoffe, M.D., Principal Investigator, H. Lee Moffitt Cancer Center and Research Institute


Verification Date

February 2017