Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer

NCT00701168 | Unknown

• 1 other identifier: LJCC 07-04
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.

Conditions

Carcinoma, Hepatocellular; Neoplasm Metastasis

Interventions

yttrium Y 90 microspheres (Therasphere®) DEVICE

This is a local therapy for unresectable liver tumors with limited treatment options. It may be repeated under special circumstances.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of primary or metastatic intrahepatic carcinoma
• The cancer must be unresectable with limited established treatment options
• ECOG Performance Status Score 0-2
• Age 19 years or older
• Able to comprehend and provide written informed consent

You may not qualify if:

• Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
• Absolute granulocyte count ≤ 1,500/ul
• Platelet count ≤ 75,000/ul
• Serum creatinine \> 2.0 mg/dl
• Serum bilirubin ≥ 2.0 mg/dl
• Any of the following contraindications to angiography and selective visceral catheterization:
• History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
• Bleeding, diathesis, not correctable by usual forms of therapy
• Severe peripheral vascular disease that would preclude catheterization
• Substantial venous shunt away from the liver
• Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of radiation to the lungs on either 1) first Therasphere® administration; or 2) cumulative delivery of radiation to the lungs over multiple treatments
• Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of established angiographic techniques to stop such flow
• Significant extrahepatic disease representing an imminent life- threatening situation outcome
• Severe liver dysfunction or pulmonary insufficiency
• Active uncontrolled infection

Sponsors & Collaborators

• Leo W. Jenkins Cancer Center: lead

Study Sites (1)

Leo W Jenkins Cancer Center at East Carolina University School of Medicine

Greenville, North Carolina, 27834, United States

Location

Related Publications (65)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne Russo, MD

  East Carolina University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Last Updated: August 23, 2017

Record last verified: 2017-08

Locations

US (1)