Condition category
Cancer
Date applied
15/02/2016
Date assigned
17/02/2016
Last edited
17/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Dr George Peoples

ORCID ID

Contact details

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

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 measures

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

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

www.perseuspci.com

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

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes