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

Primary Purpose

Advanced Hepatocellular Carcinoma

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
TheraBionic device
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Disciplina de Transplante e Cirurgia do Fígado

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 24, 2007
Last Updated
September 24, 2007
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00534664
Brief Title
Phase I/II Study of Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma
Acronym
TheraBionic
Official Title
Phase II Study to Determine the Effectiveness of Intrabuccally Administered Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
TheraBionic device
Intervention Description
Daily outpatient treatment with theraBionic device

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederico P Costa, MD
Organizational Affiliation
Disciplina de Transplante e Cirurgia do Fígado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Disciplina de Transplante e Cirurgia do Fígado
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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