Safety of 32P BioSilicon in Patients With Hepatocellular Carcinoma

NCT00247260 | Unknown Phase 2

• 1 other identifier: BIOSP 202
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Brachytherapy is a recent technique used in the treatment of tumours and involves the use of radioactive sources brought into close contact with the target tissues. One of the principal benefits of brachytherapy is that high radiation doses can be localised within the tumour with the consequence of minimal side effects. 32P is a radionuclide ideal for brachytherapy as it has high energy beta emitting properties, typically a maximum tissue range of about 8 mm and a half life of 14.3 days. 32P BioSiliconTM is an active implantable medical device encapsulating 32P within the internal microcrystalline structure of highly pure inert silicon and acts as a sealed source for the provision of 32 phosphorous. Tumours targeted with 32P BioSiliconTM are hypothesized to show a reduction in volume with a low incidence of side effects associated with the treatment. Prolongation of survival and improved quality of life would be favourable outcomes of the investigational product.

Conditions

Liver Cancer

Keywords

HCC; Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

• This is a multicentre, open label study to evaluate the safety and efficacy of three escalating radioactivity levels (MBq) of 32P BioSiliconTM in patients with unresectable hepatocellular carcinoma

Secondary Outcomes (6)

• To evaluate the safety profile of three escalating radioactivity levels (MBq) of 32P BioSiliconTM given as intratumoural implantations in patients with unresectable hepatocellular carcinoma

• To evaluate the systemic distribution of 32P BioSiliconTM and soluble P32, following the intratumoural implantations

• To evaluate the safety and performance of the SIMPLTM needle

• To evaluate the target tumour response of three escalating radioactivity levels (MBq) of 32P BioSiliconTM

• To evaluate the duration of target tumour response and overall survival rates

Interventions

32P BioSilicon DEVICE

Eligibility Criteria

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

You may qualify if:

• Written informed consent.
• Male or female patients equal to or greater than 18 years old.
• Patients with diagnosis of hepatocellular carcinoma (HCC) meeting one of the criteria below:
• Histology OR
• Radiological evidence'\*' of HCC demonstrated by dynamic contrast enhanced computed tomography (CT) or dynamic contrast enhanced magnetic resonance imaging (MRI) \>/ 1cm AND serum AFP of at least 400 mcg/L OR
• Radiological evidence'\*' of HCC demonstrated by dynamic contrast CT or dynamic contrast enhanced MRI \>/ 1cm AND serology positive for hepatitis B or C infection.
• '\*' Criteria for radiological evidence of HCC are: central enhancement on hepatic arterial phase AND wash out on portal venous or delayed phase.
• Hepatic tumour mass not amenable to surgical resection or patient refuses surgery.
• ECOG performance status 0 - 2.
• Okuda stage I - II
• Total volume of any single treatable tumour not more than 65 cc (not more than approximately 5 cm in longest dimension).
• Total treatable volume of not more than 125 cc (Group 1), 111 cc (Group 2), 139 cc (Group 3) - as defined by maximum radioactivity level (MBq) for the respective groups.
• Adequate haematological, renal and hepatic functions as defined by the following laboratory values obtained within 14 days prior to Visit 2
• Absolute granulocyte count (AGC) \>/1500 cells/mm3
• Serum creatinine \< 2 times upper limit of normal (ULN)

You may not qualify if:

• Clinical encephalopathy
• Patients younger than 18 years old.
• No life threatening tumours in other sites (e.g. brain)
• Less than four weeks after local therapy with radiofrequency ablation (RFA), or ethanol, and less than six weeks after local therapy with transarterial chemoembolization therapy (TACE), or since prior chemotherapy or biologic therapy (e.g. immunotherapy, systemic vaccine therapy).
• Prior radiotherapy to liver, pancreas or gastrointestinal tract.
• Total volume for each tumour is greater than 65 cc (greater than approximately 5 cm in longest dimension).
• Amenable to surgery.
• Pregnant or lactating females.
• Other diagnosed malignancy within the last five years, which may impact on study outcome.
• Life expectancy of less than 12 weeks.
• Patients with a significant history of cardiac disease, that is, uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the past three months and cardiac ventricular arrhythmias requiring medication.
• Patients with serious active infection or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment at implantation visits.
• Patients with any condition (e.g. psychological) that does not permit compliance with the protocol.
• Patients who are known to be HIV positive. Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection.

Sponsors & Collaborators

• pSiVida Limited: lead
• pSiOncology Private Limited: collaborator

Study Sites (1)

Singapore General Hospital

Outram Road, 169608, Singapore

Location

Related Links

• BrachySil A Novel Targeted Cancer Therapy

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Pierce Chow

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 31, 2005
• First Posted: November 1, 2005
• Study Start: October 1, 2005
• Study Completion: February 1, 2007
• Last Updated: March 15, 2007

Record last verified: 2005-10

Locations

SG (1)