Phase I/II Study of Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma (TheraBionic)

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00534664
First received: September 24, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

The goal of this study is to investigate the safety and feasibility of treating patients with advanced hepatocellular carcinoma with a noninvasive device administering low level of amplitude-modulated electromagnetic fields.


Condition Intervention Phase
Advanced Hepatocellular Carcinoma
Device: TheraBionic device
Phase 1
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: Phase II Study to Determine the Effectiveness of Intrabuccally Administered Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Enrollment: 40
Study Start Date: October 2005
Study Completion Date: February 2007
Intervention Details:
    Device: TheraBionic device
    Daily outpatient treatment with theraBionic device
  Eligibility

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

Inclusion Criteria:

  • Advanced biopsy-proven HCC
  • Performance status ECOG 0-1
  • Patients with Child Pugh A and B cirrhosis scores
  • Absence of medical or psychiatric contraindication which, in the opinion of the treating investigator, would make the patient's participation in this trial inappropriate.
  • Presence of one or more measurable lesion(s) according to the RECIST criteria.
  • Lesions treated with chemoembolization or ablation by means of radio frequencies will not be considered measurable in this study.
  • Patients on a liver transplant waiting list may be included
  • Patient must not have curative treatment options other than liver transplant
  • Patient may have been treated with intrahepatic treatment (chemoembolization or intrahepatic chemotherapy) or conventional chemotherapy or sorafenib or other experimental therapies prior to study entry. There is no limit for the number of prior therapies
  • Extra hepatic metastases do not constitute an exclusion criterion, except for active CNS metastases.
  • At least 4 weeks must have elapsed since administration of any anti-cancer treatment.
  • Other anti-cancer treatments are not permitted during this study
  • Patients must be more than 18 old and must be able to understand and sign an informed consent.
  • Patient must agree to be followed up according to the study protocol.
  • Patients may have either stable disease or disease progression according to the principal investigator assessment.
  • Patients who carry a pacemaker or any other implantable electronic device are not allowed in the study

Exclusion Criteria:

  • Suspected or biopsy confirmed brain metastases
  • Patients with hepatic cirrhosis with Child-Pugh class C
  • Patients who have received a liver transplant.
  • Patients who had a surgical resection of the disease and who do not have measurable disease.
  • Pregnant women
  • Patients who still show objective response (complete or partial response) according to the RECIST criteria due to the last anti-cancer therapy
  • Patients diagnosed with another type of cancer (excluding basal cell carcinoma) during the last five last years or whose cancer diagnosed previously is not in remission
  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: NCT00534664

Locations
Brazil
Disciplina de Transplante e Cirurgia do Fígado
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Frederico P Costa, MD Disciplina de Transplante e Cirurgia do Fígado
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00534664     History of Changes
Other Study ID Numbers: THBC-HCC-01
Study First Received: September 24, 2007
Last Updated: September 24, 2007
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on September 16, 2014