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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 November 2014 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00532740
First received: September 18, 2007
Last updated: November 12, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Metastatic Cancer
Radiation: Yttrium Y 90 glass microspheres
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 500
Study Start Date: December 2004
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532740

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer    312-695-1301    cancertrials@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Riad Salem, MD Robert H. Lurie Cancer Center
  More Information

Publications:
Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00532740     History of Changes
Other Study ID Numbers: NU 1365-002, P30CA060553, NU-1365-002
Study First Received: September 18, 2007
Last Updated: November 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
liver metastases
advanced adult primary liver cancer

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms by Site
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014