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Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma


N/A
18 Years
85 Years
Not Enrolling
Both
Liver Cancer

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Trial Information

Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma


OBJECTIVES:

Primary

- Determine tumor response to selective internal radiation therapy comprising yttrium Y
90 resin microspheres (Sir-Spheres®) in patients with unresectable primary
hepatocellular carcinoma.

Secondary

- Determine the toxicity of this regimen in these patients.

- Determine the health-related quality of life of patients receiving this regimen.

- Determine the survival of patients receiving this regimen.

OUTLINE: Patients undergo selective internal radiation therapy comprising yttrium Y 90 resin
microspheres (Sir-Spheres®) via catheter directly into the hepatic artery on day 1.

Health-related quality of life is assessed prior to initial treatment and then periodically
thereafter.

After completion of study treatment, patients are followed periodically for 12-24 months.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.


Inclusion Criteria:



- Diagnosis of hepatocellular carcinoma

- Not amenable to surgical resection or immediate liver transplantation

- Destaging of tumor prior to surgical resection or transplantation allowed

- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
dimension (longest diameter to be recorded) ≥ 10 mm by contrasted CT scan

- No equivocal, nonmeasurable, or nonevaluable liver cancer

- No more than 75% replacement of normal liver by tumor

- Cancer of the Liver Italian Program (CLIP) stage 1-3 disease

- No extra-hepatic metastases as determined by CT scan or MRI

Exclusion Criteria:

- Life expectancy ≥ 3 months

- Karnofsky performance status 50-100%

- Creatinine ≤ 1.5 mg/dL

- Bilirubin ≤ 2.0 mg/dL

- Albumin ≥ 3 g/dL

- Granulocyte count ≥ 1,500/mm³

- Platelet count ≥ 65,000/mm³

- INR ≤ 1.4

- Hemoglobin > 9 g/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment

- No nonmalignant disease that would render the patient ineligible for treatment
according to this protocol

- No hepatic arterial anatomy that would prevent the administration of study drug into
the liver

- Less than 20% arteriovenous lung shunting on a technetium 99m-labeled macroaggregated
albumin nuclear scan

- No other malignancy within the past 5 years except for cured basal cell carcinoma of
the skin or cured carcinoma in situ of the uterine cervix

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 90 days since prior surgery, chemotherapy, or locally ablative technique
for the liver cancer

- More than 4 weeks since prior and no other concurrent investigational drug or
agent/procedure (i.e., participation in another trial)

- No prior radiotherapy to the upper abdomen that included the liver in the treatment
field

- No capecitabine within 8 weeks before or after study treatment

- No other anticancer treatment (except surgical resection) for liver cancer during and
for 3 months after completion of study treatment

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response

Outcome Description:

All uni-dimensional measurable lesions (longest diameter >20mm with conventional techniques and >10mm with spiral CT scans) up to a maximum of five lesions per organ with a maximum of 10 lesions in total are used to determine response.

Outcome Time Frame:

up to 12 months

Safety Issue:

No

Principal Investigator

Steven G. Meranze, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

VICC GI 0364

NCT ID:

NCT00469963

Start Date:

December 2003

Completion Date:

April 2007

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • advanced adult primary liver cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838