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

September 24, 2007
September 24, 2007
October 2005
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No Changes Posted
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Phase I/II Study of Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma
Phase II Study to Determine the Effectiveness of Intrabuccally Administered Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Hepatocellular Carcinoma
Device: TheraBionic device
Daily outpatient treatment with theraBionic device
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00534664
THBC-HCC-01
No
Not Provided
University of Sao Paulo
Not Provided
Principal Investigator: Frederico P Costa, MD Disciplina de Transplante e Cirurgia do Fígado
University of Sao Paulo
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP