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A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver

Phase 2
18 Years
Open (Enrolling)
Liver Cancer, Metastatic Cancer

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Trial Information

A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver


- Provide supervised access to treatment with yttrium Y 90 glass microspheres
(TheraSphere®) to eligible patients who are not candidates for surgical resection of
metastatic intrahepatic carcinoma.

- Evaluate patient experience and toxicities associated with yttrium Y 90 glass
microspheres treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through
a percutaneously placed catheter into the hepatic artery. Patients may receive additional
therapy 4-12 weeks after initial treatment at the discretion of the study physician.

After completion of study therapy, patients are followed at 2 weeks, 30 days, and then once
a year for approximately 2 years.

Inclusion Criteria


- Confirmed diagnosis of metastatic intrahepatic carcinoma

- Histopathology confirmation may be waived in patients with a radiographically
identifiable liver mass AND known laboratory or clinical risk factors for cancer
or elevated tumor markers such as AFP

- Unresectable disease

- No portal hypertension with portal venous shunt away from the liver

- FDA approval to receive compassionate use of yttrium Y 90 glass microspheres

- No significant extrahepatic disease representing an imminent life-threatening outcome

- No evidence of potential delivery of > 16.5 mCi (30 Gy absorbed dose) of radiation to
the lungs on either of the following:

- First administration of yttrium Y 90 glass microspheres (TheraSphere ®)

- Cumulative delivery of radiotherapy to the lungs over multiple treatments


- ECOG performance status 0-2

- Life expectancy ≥ 3 months

- Absolute granulocyte count ≥ 1,500/µL

- Platelet count ≥ 25,000/μL

- Creatinine ≤ 2.0 mg/dL (unless using non-iodinated contrast or on dialysis)

- Serum bilirubin ≤ 3.0 mg/dL (in some cases where there is an elevated bilirubin, and
the tumor may be isolated from a vascular standpoint, treatment may proceed)

- No contraindication to angiography or selective visceral catheterization, including
any of the following:

- History of severe allergy or intolerance to any contrast media, narcotics,
sedatives, or atropine, that cannot be controlled using basic angiographic

- Bleeding diathesis, not correctable by usual forms of therapy

- Severe peripheral vascular disease that would preclude catheterization

- No severe liver dysfunction or pulmonary insufficiency

- No active uncontrolled infection

- No significant underlying medical or psychiatric illness

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No evidence of any detectable technetium-99 macroaggregated albumin (Tc-99 MAA) flow
to the stomach or duodenum after application of established angiographic techniques
to stop such flow

- No comorbid disease or condition that would preclude safe delivery of yttrium Y 90
glass microspheres and place patient at undue risk


- See Disease Characteristics

- More than 4 weeks since prior radiotherapy

- More than 2 weeks since prior surgery

- At least 2 weeks since prior radiosensitizing chemotherapy

- More than 6 weeks since prior carmustine (BCNU) or mitomycin C

- No other concurrent cancer therapy

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Patient experience and toxicity associated with TheraSphere® treatment

Outcome Description:

Evaluate patient experience and toxicities associated with TheraSphere® treatment.

Outcome Time Frame:

During & at completion of treatment.

Safety Issue:


Principal Investigator

Riad Salem, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Food and Drug Administration

Study ID:

NU 1365-002



Start Date:

December 2004

Completion Date:

April 2015

Related Keywords:

  • Liver Cancer
  • Metastatic Cancer
  • liver metastases
  • advanced adult primary liver cancer
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611