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: June 5, 2014
Last verified: February 2014
  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:
  • Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST) [ Time Frame: From the date of first treatment until date of first documented progression; median patient follow-up 30 months ] [ Designated as safety issue: No ]
    Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Time from first TheraSphere treatment to death; median follow up 30 months ] [ Designated as safety issue: No ]
    Duration of survival from date of first TheraSphere treatment to date of death or censored to last known date alive.


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)
Arms Assigned Interventions
Experimental: TheraSphere
Single arm, TheraSphere Yttrium 90 glass microspheres at 120 Gy +/- 10%; stratified by type of disease (colorectal cancer, neuroendocrine cancer, non-colorectal/non-neuroendocrine cancer
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)
  • Eastern Cooperative Oncology Group (ECOG) performance status 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
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: 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
Results First Received: October 17, 2013
Last Updated: June 5, 2014
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
Methamphetamine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014