Liver CancerPhase 2NCT00247260
Safety of 32P BioSilicon in Patients With Hepatocellular Carcinoma
A Phase 2 study testing 32P BioSilicon in people with Liver Cancer, run by pSiVida Limited at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- 32P BioSilicon
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2005to Feb 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- '' 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)
- Serum bilirubin < 3 times ULN
- ALT (SGPT) < 5 times ULN and/or AST (SGOT) < 5 times ULN within 24 hours prior to implantation (Supportive care and correction permitted) Platelet count >/ 60,000/mm3 (60 x 10^9/L)
- Prothrombin time < 3 seconds prolonged
- Women of childbearing potential must have a negative urine pregnancy test within three days of Visit 2.
- Contraception must be used (both male and female) for six months after implantation and during the duration of the whole study.
- Patients must be accessible for treatment and follow up.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Safety Profile of Three Escalating Radioactivity Levels of 32P BioSilicon Delivered With the SIMPL Needle as Intratumoural Implantations in Patients With Unresectable Hepatocellular Carcinoma
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.
Read the detailed description
The study will enroll between 48 to 50 patients from all sites. Patients will be enrolled sequentially into the three groups, starting wth Group 1 which will investigate the lower radioactivity level and then progress to a higher radioactivity level in Group 2 and then Group 3. The approval to enrol patients into the next group will be assessed and determined by a Data Monitoring Board. All patients will be followed up to 52 weeks from the start date of primary implantations.
Patients will receive intratumoural implantations of 32P BioSiliconTM under imaging guidance and local anaesthesia by designated interventional radiologists, using the SIMPL needle or conventional needles depending on the size and location of the tumour as assessed by the designated interventional radiologists. There are only a designated number of sites that will perform the implantation procedure although there are multiple sites recruiting and following up with patients.
- Tumour assessment, tumour calculation and measurement will be performed by an independent radiologist. CT scans from all participating sites will be sent in DICOM format to the designated radiologist for assessment.
- Safety assessment and grading of CTCAE will be performed by the same investigator for that same patient throughout the entire study period. There will be an interim analysis when all patients complete 24 weeks evaluating the safety profile and target tumour response of the patients.
- 32P BioSiliconTM will be prepared by designated personnel licensed to handle radioactive products and all radioactive waste will be handed and managed as per the institution's guidelines and in compliance with local regulatory requirements.
- Conditions
- Liver Cancer
- Being tested
- 32P BioSilicon
- Keywords
- HCC, Primary Liver Cancer
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
32P BioSiliconDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
To evaluate the association between tumour marker serum alpha-fetoprotein (AFP) and target tumour response with the three radioactivity levels (MBq)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startOct 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- pSiVida Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- pSiOncology Private Limited
- Investigators
- Pierce Chow, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247260
- Sponsor's protocol ID
- BIOSP 202
- Status last verified
- Oct 2005
- First submitted
- 31 Oct 2005
- Last updated
- 15 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety Profile of Three Escalating Radioactivity Levels of 32P BioSilicon Delivered With the SIMPL Needle as Intratumoural Implantations in Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00247260
- Acronym / sponsor ID
- BIOSP 202
- Conditions
- Liver Cancer
- Keywords
- HCC, Primary Liver Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- pSiVida LimitedIndustry (pharma, biotech, devices)
- Collaborators
- pSiOncology Private Limited
- Study start
- Oct 2005
- Study completion
- Feb 2007
- First posted
- 1 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will enroll between 48 to 50 patients from all sites. Patients will be enrolled sequentially into the three groups, starting wth Group 1 which will investigate the lower radioactivity level and then progress to a higher radioactivity level in Group 2 and then Group 3. The approval to enrol patients into the next group will be assessed and determined by a Data Monitoring Board. All patients will be followed up to 52 weeks from the start date of primary implantations.
Patients will receive intratumoural implantations of 32P BioSiliconTM under imaging guidance and local anaesthesia by designated interventional radiologists, using the SIMPL needle or conventional needles depending on the size and location of the tumour as assessed by the designated interventional radiologists. There are only a designated number of sites that will perform the implantation procedure although there are multiple sites recruiting and following up with patients.
- Tumour assessment, tumour calculation and measurement will be performed by an independent radiologist. CT scans from all participating sites will be sent in DICOM format to the designated radiologist for assessment.
- Safety assessment and grading of CTCAE will be performed by the same investigator for that same patient throughout the entire study period. There will be an interim analysis when all patients complete 24 weeks evaluating the safety profile and target tumour response of the patients.
- 32P BioSiliconTM will be prepared by designated personnel licensed to handle radioactive products and all radioactive waste will be handed and managed as per the institution's guidelines and in compliance with local regulatory requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- '' 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 32P BioSilicon | Device | – |
Primary outcome
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
6 secondary outcomes
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
To evaluate the association between tumour marker serum alpha-fetoprotein (AFP) and target tumour response with the three radioactivity levels (MBq)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2007.
- BrachySil A Novel Targeted Cancer TherapyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierce Chow principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 32P BioSilicon in people with Liver Cancer, run by pSiVida Limited at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2007.