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Trial record 2 of 28 for:    Polaris Group

Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular Carcinoma (TACE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Polaris Group
ClinicalTrials.gov Identifier:
NCT02006030
First received: November 27, 2013
Last updated: February 7, 2017
Last verified: September 2016
  Purpose
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that require arginine. In this study, the investigators will evaluate the response rate, as determined by the revised International Working Group recommendations.

Condition Intervention Phase
Unresectable Hepatocellular Carcinoma
Drug: ADI-PEG 20
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Randomized, Open Label, Phase 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma

Further study details as provided by Polaris Group:

Primary Outcome Measures:
  • Determine time to tumor progression (TTP) [ Time Frame: 2 years estimated - course of study ]

Secondary Outcome Measures:
  • Tumor response rates [ Time Frame: 2 years estimated - course of study ]

Estimated Enrollment: 40
Study Start Date: June 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADI-PEG 20
arginine deiminase formulated with polyethylene glycol
Drug: ADI-PEG 20

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of HCC confirmed clinically or histologically or cytologically. A clinical diagnosis of HCC, using the 2010 Guideline of the American Association for the Study of Liver Diseases requires the presence of hepatic tumor(s) with image findings (e.g. sonography, CT or MRI) compatible with HCC, and no evidence of other gastrointestinal tumors (Bruix [2011] - Guideline, 2010).
  2. Solitary hepatic tumor <8 cm in diameter or multifocal disease as evidenced by CT or MRI scan. Tumor volume ≥50% of liver organ or infiltrating HCC should be excluded.
  3. Not a candidate for surgical resection or ablation of the tumor.
  4. The target lesion must not have been treated previously with local therapy, including TACE. Prior local therapy (radiofrequency ablation, percutaneous ethanol injection, cryoablation, or surgery) to nontarget lesions is acceptable.
  5. The subject must have received no more than 2 TACE (n≤ 2) or the previous TACE was performed longer than 2 months before enrollment.
  6. Local therapy must have been completed at least 4 weeks before baseline scan.
  7. Measurable disease using mRECIST criteria (Appendix A) and RECIST1.1 (Appendix B) criteria. At least 1 measurable lesion must be present.
  8. Barcelona Clinic Liver Cancer (BCLC) staging classification B (intermediate stage) (Appendix C).

Exclusion Criteria:

  1. 1. Candidate for potential curative therapies (i.e., resection or transplantation).
  2. Prior allograft transplantation including liver transplantation.
  3. Significant cardiac disease (New York Heart Association Class III or IV; Appendix F).
  4. Serious infection requiring treatment with systemically administered antibiotics.
  5. Pregnancy or lactation.
  6. Expected non-compliance.
  7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.
  8. Subjects who have had any anticancer treatment within 2 weeks prior to week 1 visit.
  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: NCT02006030

Locations
Taiwan
CMUH
Taichung City, Taiwan
TP-VGH
Taipei City, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
CGMH-LK
Taoyuan, Taiwan
Sponsors and Collaborators
Polaris Group
Investigators
Principal Investigator: Pei-Jer Chen, MD, PhD National Taiwan University Hospital Taipei, Taiwan
  More Information

Responsible Party: Polaris Group
ClinicalTrials.gov Identifier: NCT02006030     History of Changes
Other Study ID Numbers: POLARIS2013-003
Study First Received: November 27, 2013
Last Updated: February 7, 2017

Keywords provided by Polaris Group:
Unresectable Hepatocellular Carcinoma
Liver Cancer
ADI
ADI-PEG 20

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 24, 2017