Radiolabeled Glass Beads in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00532740
First received: September 18, 2007
Last updated: May 9, 2014
Last verified: May 2014

September 18, 2007
May 9, 2014
December 2004
April 2015   (final data collection date for primary outcome measure)
Patient experience and toxicity associated with TheraSphere® treatment [ Time Frame: During & at completion of treatment. ] [ Designated as safety issue: Yes ]
Evaluate patient experience and toxicities associated with TheraSphere® treatment.
  • Proportion of patients completing scheduled treatment plan
  • Response
  • Survival time
  • Adverse experiences
Complete list of historical versions of study NCT00532740 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Radiolabeled Glass Beads in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.

PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating patients with metastatic liver cancer that cannot be removed by surgery.

OBJECTIVES:

  • 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with metastatic cancer of the liver who are not surgical resection candidates.

  • Liver Cancer
  • Metastatic Cancer
Radiation: Yttrium Y 90 glass microspheres
Between 0.2 to 0.5 Curies (200-500-mCi), either single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart per treating physician's discretion.
All Patients
Patients with metastatic cancer of the liver who are not surgical resection candidates and who will be treated with TheraSphere per institutional standard of care.
Intervention: Radiation: Yttrium Y 90 glass microspheres

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
April 2016
April 2015   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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 techniques
    • 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

PRIOR CONCURRENT THERAPY:

  • 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
Both
18 Years and older
No
United States
 
NCT00532740
NU 1365-002, P30CA060553, NU-1365-002
Yes
Northwestern University
Northwestern University
National Cancer Institute (NCI)
Study Chair: Riad Salem, MD Robert H. Lurie Cancer Center
Northwestern University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP