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SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma

Primary Purpose

Carcinoma, Hepatocellular, Hepatoma

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SIR-Spheres microspheres

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring unresectable hepatocellular carcinoma, HCC, SIR-Spheres, Y-90 Microspheres, brachytherapy, Selective Internal Radiation Therapy (SIRT), liver cancer

Eligibility Criteria

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

Inclusion Criteria:

must have a confirmed diagnosis of HCC.
at least 18 years of age.
must have a confirmed diagnosis of HCC either by histological confirmation or, in a subject who exhibits a vascular liver mass in the presence of radiographically apparent cirrhosis, an alpha-fetoprotein (AFP) level greater than 500 International Units/milliliter (UI/ml).
must present HCC that is not amenable to surgical resection or immediate liver transplantation, or that is not optimally treatable with local ablative techniques such as radio-frequency ablation due to its size, extent or presence of cirrhosis.
must present measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 10 mm with spiral CT scan or greater than or equal to 20 mm using conventional techniques (CT, MRI).
must present with a whole-liver tumor burden of greater than or equal to 15% and less than or equal to 70%
must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
must have normal organ and marrow function

Exclusion criteria:

Includes both the listed contraindications to SIR-Spheres® and the exclusion criteria specific to the setting of this investigational study:

hepatic artery directed therapy within the previous 6 months.
chemotherapy within the previous 4 weeks
have not recovered from adverse events due to agents administered previously
Prior external hepatic radiation therapy for HCC, more than two prior systemic chemotherapy regimes for HCC or any other concomitant therapy for HCC
Currently receiving any other investigational agents for the treatment of their cancer.
Any extra-hepatic metastases other than metastatic disease found in the lung, bone and/or abdominal lymph nodes that are not otherwise life limiting.
Any other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.
Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
Any of the following contraindications to angiography and selective visceral catheterization:
- Bleeding diathesis
- Severe peripheral vascular disease
- Portal hypertension with hepatofugal flow
Female subjects who are pregnant or currently breastfeeding.
Refusal or inability to use effective means of contraception in men or women of childbearing potential.
Current enrollment in any other investigational drug or device study.

Sites / Locations

Thomas Jefferson University - Kimmel Cancer Center
UPMC Liver Cancer Center
The Liver Institute at Methodist Dallas
MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SIR-Spheres microspheres

Arm Description

SIR-Spheres microspheres

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events Grade 3 or Higher

Using the National Cancer Institute Common Terminology Criteria (NCI-CTC) version 3.0 as recorded in the case report form.

Secondary Outcome Measures

Time to Disease Progression

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Tumor Response Rate

Tumour response rates estimated by the proportion of patients with a best response of CR, PR or SD by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) with corresponding exact 90% confidence limits being reported. Per RECIST v1.0 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Change From Baseline in Health-related Quality of Life

Overall Survival

Overall Survival is defined as the time interval between the date of enrollment and the date of death from any cause.

Full Information

NCT ID

NCT00503867

First Posted

July 18, 2007

Last Updated

November 16, 2020

Sponsor

Sirtex Medical

1. Study Identification

Unique Protocol Identification Number

NCT00503867

Brief Title

SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma

Official Title

A Pilot Study of Yttrium-90 Microspheres (SIR-Spheres®) Therapy for the Treatment of Unresectable Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Why Stopped

Low patient recruitment

Study Start Date

July 18, 2007 (Actual)

Primary Completion Date

March 9, 2010 (Actual)

Study Completion Date

March 9, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sirtex Medical

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main purpose of this study is to determine the safety and toxicity of treatment with SIR-Spheres® in patients with unresectable primary liver cancer or hepatocellular carcinoma (HCC). Other purposes of this study include assessment of the effect of treatment on overall survival, the length of time it takes for the disease to worsen, if and how the treatment affects the patient's quality of life, and if and how the cancer responds to the treatment.

Detailed Description

This study is a multi-institutional, non-randomized pilot study that aims to assess the safety and toxicity of hepatic arterial radioembolization using SIR-Spheres yttrium-90 microspheres (SIR-Spheres microspheres) in the treatment of patients with unresectable primary hepatocellular carcinoma (HCC). The study aims to recruit 40 patients over a period of 24 months.

6. Conditions and Keywords

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

Carcinoma, Hepatocellular, Hepatoma

Keywords

unresectable hepatocellular carcinoma, HCC, SIR-Spheres, Y-90 Microspheres, brachytherapy, Selective Internal Radiation Therapy (SIRT), liver cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SIR-Spheres microspheres

Arm Type

Experimental

Arm Description

SIR-Spheres microspheres

Intervention Type

Device

Intervention Name(s)

SIR-Spheres microspheres

Intervention Description

SIR-Spheres Yttrium-90 microspheres

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events Grade 3 or Higher

Description

Using the National Cancer Institute Common Terminology Criteria (NCI-CTC) version 3.0 as recorded in the case report form.

Time Frame

From date of enrollment until the date of death from any cause assessed up 24 weeks.

Secondary Outcome Measure Information:

Title

Time to Disease Progression

Description

Time Frame

From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

Title

Tumor Response Rate

Description

Time Frame

From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

Title

Change From Baseline in Health-related Quality of Life

Time Frame

52 weeks

Title

Overall Survival

Description

Overall Survival is defined as the time interval between the date of enrollment and the date of death from any cause.

Time Frame

From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: must have a confirmed diagnosis of HCC. at least 18 years of age. must have a confirmed diagnosis of HCC either by histological confirmation or, in a subject who exhibits a vascular liver mass in the presence of radiographically apparent cirrhosis, an alpha-fetoprotein (AFP) level greater than 500 International Units/milliliter (UI/ml). must present HCC that is not amenable to surgical resection or immediate liver transplantation, or that is not optimally treatable with local ablative techniques such as radio-frequency ablation due to its size, extent or presence of cirrhosis. must present measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 10 mm with spiral CT scan or greater than or equal to 20 mm using conventional techniques (CT, MRI). must present with a whole-liver tumor burden of greater than or equal to 15% and less than or equal to 70% must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. must have normal organ and marrow function Exclusion criteria: Includes both the listed contraindications to SIR-Spheres® and the exclusion criteria specific to the setting of this investigational study: hepatic artery directed therapy within the previous 6 months. chemotherapy within the previous 4 weeks have not recovered from adverse events due to agents administered previously Prior external hepatic radiation therapy for HCC, more than two prior systemic chemotherapy regimes for HCC or any other concomitant therapy for HCC Currently receiving any other investigational agents for the treatment of their cancer. Any extra-hepatic metastases other than metastatic disease found in the lung, bone and/or abdominal lymph nodes that are not otherwise life limiting. Any other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years. Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements. Any of the following contraindications to angiography and selective visceral catheterization: Bleeding diathesis Severe peripheral vascular disease Portal hypertension with hepatofugal flow Female subjects who are pregnant or currently breastfeeding. Refusal or inability to use effective means of contraception in men or women of childbearing potential. Current enrollment in any other investigational drug or device study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ravi Murthy, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

T. Clark Gamblin, MD

Organizational Affiliation

UPMC Liver Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thomas Jefferson University - Kimmel Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

UPMC Liver Cancer Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

The Liver Institute at Methodist Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75203

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Originally there was a plan to share the data with the Data Monitoring Committee, however the study was closed early due to lack of enrollment and the Data Monitoring Committee did not convene.

Learn more about this trial

SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma

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