Plain English Summary
Background and study aims
The aim of this study is to determine the safety and effectiveness of a vaccine, made from the patient's own tumor tissue and blood, to prevent cancer recurrence in patients with solid tumors.
Who can participate?
Patients aged over 18 with solid tumors
What does the study involve?
Tumor tissue is collected during standard of care surgery along with a blood sample. The vaccine (prepared from components of the tumor and the blood) is given for a total of four times over a period of three months. The patient will continue to see their treating medical oncologist for standard of care follow up. Any adverse events and tumor response are assessed at each study visit and standard of care visit.
What are the possible benefits and risks of participating?
Patients may develop an immune response that may prevent recurrence of cancer or treat an existing tumor.
Where is the study run from?
Perseus Cayman Limited (Cayman Islands)
When is the study starting and how long is it expected to run for?
November 2012 to January 2018
Who is funding the study?
Perseus PCI (USA)
Who is the main contact?
Dr George Peoples
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Autologous TLPLDC vaccine (tumor lysate, particle loaded, dendritic cells): a single-arm open-label trial
Acronym
Study hypothesis
Autologous TLPLDC vaccine prevents recurrences in resected stage III/IV or to treat stage IV solid tumors
Ethics approval
Cayman Island Health Practice Commission, 25/01/2013, registration number: HPC/HCF/129
Study design
Single-arm open-label interventional
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Resected stage III/IV solid tumor or to stage IV solid tumors
Intervention
A vaccine is made from the patient's own tumor tissue (collected during standard of care surgery) and blood. Patients will be seen for a total of four months to receive the initial vaccine and then three follow up visit vaccine inoculations (1/month). Safety and efficacy will be assessed for each patient. Follow up will be continued as per standard of care dictated by the patient's treating medical oncologist for a continual assessment of disease free status/tumor response and any adverse events. This information will be collected from the electronic medical record. Patients will be followed up to 2 years for disease progression and overall survival.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measure
Safety of of the autologous TLPLDC vaccine at baseline, month 1, 2, 3 and at each standard of care visit to the treating medical oncologist. Safety data will be collected on local and systemic toxicities and graded and reported per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Secondary outcome measures
Efficacy of the autologous TLPLDC vaccine at baseline, month 1, 2, 3 and at each standard of care visit to the treating medical oncologist. Disease-free status/tumor response will be monitored per standard of care as dictated by the patients’ treating medical oncologist. This information will be obtained from the patient and/or the referring medical oncologist. Follow-up scans will be assessed for tumor response per RECIST v1.1.
Overall trial start date
26/11/2012
Overall trial end date
01/01/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Stage III/IV (resected) solid tumor malignancy
2. Stage IV solid tumor malignancy with accessible tumor
3. Approximately 1 mg (1 cm3) of accessible and dispensable tumor that will not interfere with pathologic staging
4. ECOG 0-1 performance
5. Not involved in other clinical trials
6. Capable of giving informed consent
7. Age 18 to 99
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. ECOG >2
2. Insufficient tumor available to produce vaccine
3. Immune deficiency disease or HIV, active HBV, or active HCV
4. Steroids or other immunosuppressants
Recruitment start date
26/11/2012
Recruitment end date
01/01/2017
Locations
Countries of recruitment
Cayman Islands
Trial participating centre
Perseus Cayman Limited
KY1-1206
Cayman Islands
Sponsor information
Organisation
Perseus PCI (USA)
Sponsor details
7901 Dadiva Ct
Austin
78735
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Perseus PCI (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
01/01/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29724512