Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346281
Status:
UNKNOWN
Last Update Posted:
2006-06-29
First Post:
2006-06-27
Brief Title:
32P BioSiliconTM in Addition to Gemcitabine in Pancreatic Cancer
Sponsor:
pSiMedica Limited
Organization:
pSiMedica Limited
Study Overview
Official Title:
A Phase IIa Safety Study of the Active ImplantableRadiological Medical Device 32P BioSilicon Administered Intratumourally to Patients With Advanced Unresectable Pancreatic Cancer in Addition to Standard IV Gemcitabine Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2006-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is the first study investigating the safety of 32P BioSilicon in patients with advancedunresectable pancreatic cancer who are also receiving standard intravenous gemcitabine chemotherapy The secondary aims of the study will assess the implantation procedure localisation of 32P BioSilicon tumour response and survival parameters
Tumours targetted with 32P BioSilicon is hypothesized to show a reduction in tumour volume and with the low radioactivity dose that is delivered intratumourally the incidence of side effects associated with the treatment is expected to be low Prologation of survival and improved quality of life could be favourable outcomes of the investigational product
Tumours targetted with 32P BioSilicon is hypothesized to show a reduction in tumour volume and with the low radioactivity dose that is delivered intratumourally the incidence of side effects associated with the treatment is expected to be low Prologation of survival and improved quality of life could be favourable outcomes of the investigational product
Detailed Description:
This will be an open label Phase IIa safety study recruiting about 15 patients from at least two sites All patients will have 32P BioSilicon implanted into the pancreatic tumour as a single implant using endoscopic ultrasound The study will examine the safety of an injected activity equivalent to an absorbed dose of 100 Gy which is considered to be an initial low risk radioactivity level administered intratumourally to patients with pancreatic cancer All patients will receive gemcitabine treatment within 2 weeks prior to or within 3 days of implantation Any dose adjustments to the gemcitabine treatment will be made according to the clinical judgement of the oncologist in the team and this will be made in accordance with the current approved prescribing receommendations Implantation of 32P BioSilicon will be performed endoscopically by a trained endoscopist and a nuclear medicine physician The 32P BioSilicon will be prepared by a designated personnel licenced to handle radioactive products and all radioactive waste will be handled and managed as per the institutions guidelines and in compliance with local regulatory requirements Bremsstrahlung imaging will be performed post implantation as a preliminary indication of localisation of the implanted 32P BioSiliconTM
Assessments will be performed for haematology biochemistry CA19-9 marker performance status and any adverse event observed or reported will be graded according to the CTCAE To minimise inter-observer variation the patient should be assessed by the same investigator throughout the study Tumour assessment and tumour volume calculation will be performed by designated radiologists who are independent of the study To standardise the CT scans will be performed according to an agreed scanning protocol and the images will be captured in a DICOM format at site for assessment by the independent radiologist Tumour response will be evaluated only for target tumours using RECIST
Pain assessment using the Brief Pain Inventory BPI pain score will be recorded by the patient
Patients who have clinically andor radiologically stable or responding disease have the option to continue gemcitabine at the discretion of the investigator Following discontinuation from the study patients will be followed up for progression-free and overall survival
A Data Monitoring Committee will review the study data at regular teleconference throughout the study
Assessments will be performed for haematology biochemistry CA19-9 marker performance status and any adverse event observed or reported will be graded according to the CTCAE To minimise inter-observer variation the patient should be assessed by the same investigator throughout the study Tumour assessment and tumour volume calculation will be performed by designated radiologists who are independent of the study To standardise the CT scans will be performed according to an agreed scanning protocol and the images will be captured in a DICOM format at site for assessment by the independent radiologist Tumour response will be evaluated only for target tumours using RECIST
Pain assessment using the Brief Pain Inventory BPI pain score will be recorded by the patient
Patients who have clinically andor radiologically stable or responding disease have the option to continue gemcitabine at the discretion of the investigator Following discontinuation from the study patients will be followed up for progression-free and overall survival
A Data Monitoring Committee will review the study data at regular teleconference throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None