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

NCT00534664 | Completed Phase 1

• 1 other identifier: THBC-HCC-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Hepatocellular Carcinoma

Interventions

TheraBionic device DEVICE

Daily outpatient treatment with theraBionic device

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Disciplina de Transplante e Cirurgia do Fígado

São Paulo, São Paulo, 05403-000, Brazil

Location

Study Officials

• Frederico P Costa, MD

  Disciplina de Transplante e Cirurgia do Fígado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: October 1, 2005
• Study Completion: February 1, 2007
• Last Updated: September 26, 2007

Record last verified: 2007-09

Locations

BR (1)