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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
BTG International Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01253148
First received: December 1, 2010
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Cholangiocarcinoma
Device: TheraSphere® Yttrium-90 (Y-90) Microspheres
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres As First-Line Treatment For Cholangiocarcinoma

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Number of Participants With Progression Free Survival (PFS) [ Time Frame: At 1 Month, 3 Months, every 3 Months for life ] [ Designated as safety issue: No ]
    PFS is defined as the duration of time from enrollment to time of progression or death from any cause. Progression will be defined as progressive disease in the treated lobe.


Secondary Outcome Measures:
  • Number of Participants With Overall Survival (OS) [ Time Frame: From Enrollment until Death ] [ Designated as safety issue: No ]
    OS is defined as the duration of time from enrollment to time of death from any cause.

  • Number of Participants With Tumor Response [ Time Frame: At 1 Month, 3 Months, every 3 Months for life ] [ Designated as safety issue: No ]
    Tumor Response according to Response Evaluation Criteria In Solid Tumors (RECIST)

  • Number of Participants Who Experience Toxicity [ Time Frame: At 1 Month, 3 Months, every 3 Months for life ] [ Designated as safety issue: Yes ]
    Common Terminology Criteria for Adverse Events (CTCAE) v4 Toxicity


Estimated Enrollment: 41
Study Start Date: January 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arterial Injection of 90-Y Microspheres
Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
Device: TheraSphere® Yttrium-90 (Y-90) Microspheres
Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.
Other Names:
  • 90y
  • Intrahepatic Arterial Injection
  • Radiotherapy
  • Radioactive Microspheres
  • Yttrium Glass Microspheres

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253148

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
BTG International Inc.
Investigators
Principal Investigator: Ravi Shridhar, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01253148     History of Changes
Other Study ID Numbers: MCC-16236
Study First Received: December 1, 2010
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Liver
Bile Duct

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014