Autologous TLPLDC vaccine (tumor lysate, particle loaded, dendritic cells)

ISRCTN ISRCTN81339386
DOI https://doi.org/10.1186/ISRCTN81339386
Secondary identifying numbers N/A
Submission date
15/02/2016
Registration date
17/02/2016
Last edited
02/11/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr George Peoples
Scientific

110 E. Houston Street
San Antonio
78205
United States of America

Study information

Study designSingle-arm open-label interventional
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAutologous TLPLDC vaccine (tumor lysate, particle loaded, dendritic cells): a single-arm open-label trial
Study objectivesAutologous TLPLDC vaccine prevents recurrences in resected stage III/IV or to treat stage IV solid tumors
Ethics approval(s)Cayman Island Health Practice Commission, 25/01/2013, registration number: HPC/HCF/129
Health condition(s) or problem(s) studiedResected stage III/IV solid tumor or to stage IV solid tumors
InterventionA 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 typeBiological/Vaccine
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureSafety 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 measuresEfficacy 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 study start date26/11/2012
Completion date01/01/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment26/11/2012
Date of final enrolment01/01/2017

Locations

Countries of recruitment

  • Cayman Islands

Study participating centre

Perseus Cayman Limited
KY1-1206
Cayman Islands

Sponsor information

Perseus PCI (USA)
Industry

7901 Dadiva Ct
Austin
78735
United States of America

Website www.perseuspci.com
ROR logo "ROR" https://ror.org/03mfyst18

Funders

Funder type

Industry

Perseus PCI (USA)

No information available

Results and Publications

Intention to publish date01/01/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 31/05/2018 Yes No

Editorial Notes

02/11/2018: Publication reference added.
18/10/2017: Internal review.