Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma

NCT01253148 | Completed Results DMC

• 2 other identifiers: MCC-16236NCI-2011-00794
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if Therasphere will be a better way to treat cholangiocarcinoma. The investigators want to find out what effects, good and/or bad, this treatment will have on the patient and their cancer.

Conditions

Cholangiocarcinoma

Keywords

Liver; Bile Duct

Outcome Measures

Primary Outcomes (1)

• Median Progression Free Survival (PFS)

  PFS is defined as the duration of time from enrollment to time of progression or death from any cause. Progression will be defined as progressive disease in the treated lobe. If progression is seen in a treated lobe, this will be considered a treatment failure. Progressive Disease (PD) according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.1.: At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  End of post treatment follow-up period of 20 months

Secondary Outcomes (2)

• Median Overall Survival (OS)

  Up to 36 months

• Overall Response Rate (ORR)

  End of post treatment follow-up period of up to 20 months

Study Arms (1)

Arterial Injection of 90-Y Microspheres

EXPERIMENTAL

Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma

Device: TheraSphere® Yttrium-90 (Y-90) Microspheres

Interventions

TheraSphere® Yttrium-90 (Y-90) Microspheres DEVICE

Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.

Also known as: 90y, Intrahepatic Arterial Injection, Radiotherapy, Radioactive Microspheres, Yttrium Glass Microspheres

Arterial Injection of 90-Y Microspheres

Eligibility Criteria

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

You may qualify if:

• Patients must have newly diagnosed or recurrent (post surgery) histologically or cytologically proven cholangiocarcinoma.
• Patients can have solitary, multifocal unilobar, or bilobar disease without evidence of extrahepatic involvement. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>10 mm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI).
• Age \>18 years
• Life expectancy of greater than 3 months based on physician judgment
• Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 (Karnofsky 50%)
• No prior chemotherapy or radiation treatment for cholangiocarcinoma
• Childs-Pugh score A or Childs-Pugh score B without portal vein thrombus
• Lung shunting that predicts lung dose to be \<30 Gy in a single treatment
• The effects of TheraSpheres on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radioactive spheres are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document
• Adequate baseline hematopoietic function:
• total white blood cell count equal to or greater than 3,000/mm³
• absolute granulocyte count greater than 1,500/mm³
• platelet count equal to or greater than 100,000/mm³
• Hemoglobin \>8.0

You may not qualify if:

• Patients receiving any other investigational agents
• Patients with extrahepatic disease
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because TheraSpheres are radioactive and radiation is a known agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TheraSpheres, breastfeeding should be discontinued if the mother is treated with TheraSpheres.
• Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. In addition, antiretrovirals are known radiation sensitizers and could dramatically increase the risk of fulminant hepatic failure. Therefore, HIV-positive patients are excluded from the study because of possible lethal side effects.
• Bulk disease (tumor volume \> 70% of the target liver volume, or tumor nodules too numerous to count)
• Aspartic transaminase (AST) or alanine transaminase (ALT) \> 5 times upper limit of normal (ULN)
• Bilirubin \> 2 mg/dL
• Child-Pugh C Liver Cirrhosis
• Tumor volume \> 50% combined with an albumin \< 3 g/dL
• Complete occlusion of main portal vein causing portal hypertension

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• BTG International Inc.: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Microspheres; Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Therapeutics

Results Point of Contact

• Title: Sarah Hoffe, M.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

sarah.hoffe@moffitt.org

813-745-3814

Study Officials

• Sarah Hoffe, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 22, 2017
• Results First Posted: October 19, 2016

Record last verified: 2017-02

Locations

US (1)