TheraSphere for the Treatment of Liver Metastases

NCT00511862 | Completed Phase 2 Results

• 1 other identifier: G040148
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Colorectal Cancer; Carcinoma, Neuroendocrine; Neoplasm Metastasis

Keywords

TheraSphere; radioactive microspheres; Yttrium-90; Yttrium glass microspheres

Outcome Measures

Primary Outcomes (1)

• Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)

  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.

  From the date of first treatment until date of first documented progression; median patient follow-up 30 months

Secondary Outcomes (1)

• Overall Survival

  Time from first TheraSphere treatment to death; median follow up 30 months

Study Arms (1)

TheraSphere

EXPERIMENTAL

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

Interventions

Yttrium 90 glass microspheres DEVICE

120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe

Also known as: TheraSphere

TheraSphere

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• BTG International Inc.: collaborator

Study Sites (5)

Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611-2927, United States

Location

John Hopkins Hospital

Baltimore, Maryland, 21287-4010, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Medical College of Wisconsin, Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Neuroendocrine; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: BTG International Canada Inc.

TheraSphereClinical@btgplc.com

613-801-1880

Study Officials

• Al Benson III, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 6, 2007
• Study Start: January 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 13, 2021
• Results First Posted: May 23, 2014

Record last verified: 2021-04

Locations

US (5)