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
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
Scientific
110 E. Houston Street
San Antonio
78205
United States of America
Study information
| Study design | Single-arm open-label interventional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Autologous TLPLDC vaccine (tumor lysate, particle loaded, dendritic cells): a single-arm open-label trial |
| Study objectives | Autologous 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 26/11/2012 |
| Completion date | 01/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 26/11/2012 |
| Date of final enrolment | 01/01/2017 |
Locations
Countries of recruitment
- Cayman Islands
Study participating centre
Cayman Islands
Sponsor information
Industry
7901 Dadiva Ct
Austin
78735
United States of America
| Website | www.perseuspci.com |
|---|---|
"ROR" |
https://ror.org/03mfyst18 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/01/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not 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.
