TheraSphere for the Treatment of Liver Metastases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT00511862
First received: August 2, 2007
Last updated: October 17, 2012
Last verified: October 2011
  Purpose

This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with metastatic disease to the liver that cannot be treated or is progressing following treatment with systemic or other liver-directed therapies.


Condition Intervention Phase
Colorectal Cancer
Carcinoma, Neuroendocrine
Neoplasm Metastasis
Device: Yttrium 90 glass microspheres
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TheraSphere for the Treatment of Liver Metastases: An Open Label Trial of TheraSphere in Patients With Liver Metastases From Primary Colorectal Cancer, Neuroendocrine Cancer or Non-colorectal/Non-neuroendocrine Cancer

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Liver progression-free survival according to RECIST criteria [ Time Frame: open-ended ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events and reportable serious adverse events [ Time Frame: All events within 3 months of TheraSphere treatment, adverse device events thereafter ] [ Designated as safety issue: Yes ]

Enrollment: 151
Study Start Date: January 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Yttrium 90 glass microspheres
    120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe
    Other Name: TheraSphere
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • diagnosis of metastatic disease to the liver that is refractory to, or inappropriate for, other systemic or liver-directed therapies
  • unresectable liver metastases
  • target tumors measurable using standard imaging techniques
  • tumor replacement < or = 50% of total liver volume (visual estimation by investigator)
  • Hypervascular tumors (visual estimation by investigator)
  • ECOG 0 - 2
  • minimum one month since most recent prior cancer therapy with the exception of patients receiving Sandostatin for neuroendocrine cancer
  • patient informed consent

Exclusion Criteria:

  • At risk of hepatic or renal failure within 21 days of treatment (serum creatinine > 2.0 mg/dL unless on dialysis; serum bilirubin ≥ 2.0 mg/dL; albumin < 2.0 mg/dL or any history of hepatic encephalopathy)
  • contraindications to angiography and selective visceral catheterization including any non-correctable bleeding diathesis or coagulopathy, severe peripheral vascular disease or history of non-management allergy or intolerance to contrast, narcotics, sedatives or atropine
  • severe liver dysfunction or presentation of pulmonary insufficiency or clinically evident history of chronic obstructive pulmonary disease
  • cirrhosis or portal hypertension
  • prior external beam radiation treatment to the liver
  • prior TheraSphere treatment to the liver
  • any intervention for, or compromise of the Ampulla of Vater
  • clinically evident ascites (trace ascites on imaging is acceptable)
  • any continuing complications of prior cancer therapy that have not improved or resolved prior to 21 days before first TheraSphere treatment
  • significant life-threatening extrahepatic disease in judgment of physician
  • concurrent enrollment in another study
  • alternative available therapies in judgement of physician
  • evidence on technetium-99m macroaggregated albumin scan that shows lung shunting > 30 Gy cumulative limit
  • evidence on technetium-99m macroaggregated albumin scan showing potential for deposition of microspheres to the gastrointestinal tract that cannot be eliminated by catheter placement or corrective action using standard angiographic techniques
  • positive serum pregnancy test in women of childbearing potential
  • co-morbid disease or condition that puts the patient at undue risk or precludes use of TheraSphere in judgment of physician
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511862

Locations
United States, Illinois
Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611-2927
United States, Maryland
John Hopkins Hospital
Baltimore, Maryland, United States, 21287-4010
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
United States, Wisconsin
Medical College of Wisconsin, Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
BTG International Inc.
Investigators
Principal Investigator: Al Benson III, MD Northwestern University
  More Information

No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00511862     History of Changes
Other Study ID Numbers: G040148
Study First Received: August 2, 2007
Last Updated: October 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by BTG International Inc.:
TheraSphere
radioactive microspheres
Yttrium-90
Yttrium glass microspheres

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Carcinoma, Neuroendocrine
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Liver Diseases

ClinicalTrials.gov processed this record on April 22, 2014