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

Primary Purpose

Cholangiocarcinoma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TheraSphere® Yttrium-90 (Y-90) Microspheres

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring Liver, Bile Duct

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arterial Injection of 90-Y Microspheres

Arm Description

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

Outcomes

Primary Outcome Measures

Median Progression Free Survival (PFS)

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. If progression is seen in a treated lobe, this will be considered a treatment failure. Progressive Disease (PD) according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.1.: At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Secondary Outcome Measures

Median Overall Survival (OS)

OS is defined as the duration of time from enrollment to time of death from any cause.

Overall Response Rate (ORR)

Tumor Response according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all target and non-target lesions; no new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions.

Full Information

NCT ID

NCT01253148

First Posted

December 1, 2010

Last Updated

February 17, 2017

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

BTG International Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01253148

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

BTG International Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiocarcinoma

Keywords

Liver, Bile Duct

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arterial Injection of 90-Y Microspheres

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

TheraSphere® Yttrium-90 (Y-90) Microspheres

Other Intervention Name(s)

90y, Intrahepatic Arterial Injection, Radiotherapy, Radioactive Microspheres, Yttrium Glass Microspheres

Intervention Description

Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.

Primary Outcome Measure Information:

Title

Median Progression Free Survival (PFS)

Description

Time Frame

End of post treatment follow-up period of 20 months

Secondary Outcome Measure Information:

Title

Median Overall Survival (OS)

Description

OS is defined as the duration of time from enrollment to time of death from any cause.

Time Frame

Up to 36 months

Title

Overall Response Rate (ORR)

Description

Time Frame

End of post treatment follow-up period of up to 20 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah Hoffe, M.D.

Organizational Affiliation

H. Lee Moffitt Cancer Center and Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

H. Lee Moffitt Cancer Center and Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

12. IPD Sharing Statement

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

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