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Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Metastatic Liver Disease From Primary Colorectal, Neuroendocrine, Cholangiocarcinoma, Melanoma, and Breast Cancers Refractory to Chemotherapy: A Pilot Study


Phase 2
18 Years
N/A
Open (Enrolling by invite only)
Both
Colorectal Neoplasms, Neuroendocrine Tumors, Cholangiocarcinoma, Melanoma, Breast Cancer

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Trial Information

Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Metastatic Liver Disease From Primary Colorectal, Neuroendocrine, Cholangiocarcinoma, Melanoma, and Breast Cancers Refractory to Chemotherapy: A Pilot Study


Inclusion Criteria:



- Diagnosis of metastatic colorectal, neuroendocrine, cholangiocarcinoma, melanoma, or
breast malignancy with liver dominant disease. Diagnosis may be made by histo- or
cyto-pathology, or by clinical and imaging criteria.

- The cancer is unresectable.

- All patients must be off all chemotherapeutic regimens for 30 days prior to and 30
days after TheraSphere treatment. Concurrent therapy with octreotide is permitted,
when appropriate.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

- Age 18 years or older.

- Able to understand informed consent.

Exclusion Criteria:

- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of
radiation to the lungs on either:

- single TheraSphere administration; or

- cumulative delivery of radiation to the lungs greater than 50 Gy over multiple
treatments.

- Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach
or duodenum, after application of established angiographic techniques to stop such
deposition.

- Previous radiation therapy to the lungs and/or to the upper abdomen

- Pregnancy

- Symptomatic lung disease.

- Significant extrahepatic disease representing an imminent life-threatening outcome.

- Active uncontrolled infection

- Any pre-treatment laboratory findings within 30 days of treatment demonstrating:

- Aspartate or alanine aminotransferase level greater than 5 times upper normal
limit.

- Serum bilirubin greater than 2 mg/dl

- Infiltrative tumor on imaging

- Tumor volume greater than 70% of liver volume

- Tumor volume greater than 50% of liver volume and serum albumin level less than
3 mg/dL

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Adverse Events

Outcome Description:

Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) will be assessed within 6 months of treatment administration. Anticipated adverse events include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, and abdominal pain.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

UCSF-SIRT-Metastases

NCT ID:

NCT01290536

Start Date:

May 2010

Completion Date:

January 2014

Related Keywords:

  • Colorectal Neoplasms
  • Neuroendocrine Tumors
  • Cholangiocarcinoma
  • Melanoma
  • Breast Cancer
  • Liver metastases
  • Breast Neoplasms
  • Neoplasms
  • Colorectal Neoplasms
  • Melanoma
  • Neoplasm Metastasis
  • Cholangiocarcinoma
  • Neuroendocrine Tumors

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