TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/14/2018 |
| Start Date: | May 2002 |
| End Date: | December 2018 |
| Contact: | Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center |
| Email: | UCstudy@uci.edu |
| Phone: | (877) 827-8839 |
A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
The purpose of this protocol is to provide TheraSphere treatment for patients with liver
cancer who cannot be treated by surgery. The effect on the tumor and any side effects of
TheraSphere treatment will be examined. This study will provide supervised and limited access
to TheraSphere treatment at University California Irvine Medical Center.
TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has
been used previously in the treatment of liver tumors. When Y-90 is incorporated into very
tiny glass beads (TheraSphere), it can be injected to the liver through blood vessels
supplying the liver. This allows a large dose of radiation to be delivered to the tumor with
less risk of toxic effects from radiation to other parts of the body or to healthy liver
tissue. The radiation from TheraSphere is contained within the body and becomes minimally
active within 7 days after treatment due to physical decay. The glass beads remain in the
body, but do not cause any health problems. TheraSphere has been approved for use in the
treatment of liver cancer in the United States by the Food and Drug Administration on a
limited basis.
cancer who cannot be treated by surgery. The effect on the tumor and any side effects of
TheraSphere treatment will be examined. This study will provide supervised and limited access
to TheraSphere treatment at University California Irvine Medical Center.
TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has
been used previously in the treatment of liver tumors. When Y-90 is incorporated into very
tiny glass beads (TheraSphere), it can be injected to the liver through blood vessels
supplying the liver. This allows a large dose of radiation to be delivered to the tumor with
less risk of toxic effects from radiation to other parts of the body or to healthy liver
tissue. The radiation from TheraSphere is contained within the body and becomes minimally
active within 7 days after treatment due to physical decay. The glass beads remain in the
body, but do not cause any health problems. TheraSphere has been approved for use in the
treatment of liver cancer in the United States by the Food and Drug Administration on a
limited basis.
This protocol provides TheraSphere treatment for patients with liver cancer who cannot be
treated by surgery. Patients with hepatocellular carcinoma will be evaluated for eligibility
for this treatment with the following: physical examination, medical history, blood tests
requiring approximately 2 tablespoons of blood, EKG, CT or MR of chest to examine lungs, CT
or magnetic resonance (MR) of abdomen to evaluate liver, stomach and intestines, and bone
scan to rule out spread of disease to bones. If eligible on initial screening, patients will
proceed to a second stage of screening, including an hepatic angiogram to confirm treatment
can be provided safely and to highlight the blood vessels supplying the liver, and a nuclear
medicine study (Tc-99m MAA scan) to display the blood flow to the lungs, stomach and
intestines.
When it is determined treatment can be delivered safely, patients will receive TheraSphere
via the hepatic artery through blood vessels supplying the liver on an outpatient basis.
treated by surgery. Patients with hepatocellular carcinoma will be evaluated for eligibility
for this treatment with the following: physical examination, medical history, blood tests
requiring approximately 2 tablespoons of blood, EKG, CT or MR of chest to examine lungs, CT
or magnetic resonance (MR) of abdomen to evaluate liver, stomach and intestines, and bone
scan to rule out spread of disease to bones. If eligible on initial screening, patients will
proceed to a second stage of screening, including an hepatic angiogram to confirm treatment
can be provided safely and to highlight the blood vessels supplying the liver, and a nuclear
medicine study (Tc-99m MAA scan) to display the blood flow to the lungs, stomach and
intestines.
When it is determined treatment can be delivered safely, patients will receive TheraSphere
via the hepatic artery through blood vessels supplying the liver on an outpatient basis.
Inclusion Criteria:
- Confirmed diagnosis of intrahepatic carcinoma. The histopathology confirmation
criterion may be waived in patients with a radiographically identifiable liver mass,
known laboratory or clinical risk factors for cancer or elevated tumor markers such as
Alpha-fetoprotein assay (AFP) (clinical diagnosis).
- The cancer must be unresectable.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2
- Age ≥ 18 years.
- Able to comprehend and read the study information sheet in accordance with
institutional and federal guidelines.
Exclusion Criteria:
- Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
- Absolute granulocyte count ≤ 1,500/ul
- Platelet count ≤ 75,000/μl
- 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.
- Portal hypertension with portal venous shunt away from the liver.
- Evidence of potential delivery of greater than 16.5 millicurie (mCi) (30 Gy absorbed
dose) of radiation to the lungs on either: 1) first TheraSphere administration; or 2)
cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments.
- Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after
application of established angiographic techniques to stop such flow.
- Significant extrahepatic disease representing an imminent life-threatening outcome.
- Severe liver dysfunction or pulmonary insufficiency.
- Active uncontrolled infection.
- Significant underlying medical or psychiatric illness.
- Pregnant women may not participate.
We found this trial at
1
site
Orange, California 92868
Principal Investigator: David K Imagawa, MD, PhD
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