CAM-PLEX
Research type
Research Study
Full title
To assess the safety of continuous IV administration of the CXCR4 antagonist, plerixafor (Mozobil), at potentially active plasma concentrations and assess its impact on the immune microenvironment in patients with advanced pancreatic, high grade serous ovarian and colorectal adenocarcinomas
IRAS ID
155305
Contact name
Duncan Jodrell
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Eudract number
2014-000117-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Pancreatic, ovarian and colorectal cancers are difficult to treat using chemotherapy and immune therapies; therefore there is a great need to identify novel therapeutic approaches. Currently most patients are offered treatment with a standard chemotherapy drug depending on their cancer type. Recently, laboratory studies have shown that a drug called plerixafor (Mozobil) may help the body to overcome resistance to immune therapy.
This is a prospective, non-randomised, open label, Phase I, dose escalation study of plerixafor (MozobilTM) in patients with histological documentation of advanced pancreatic, high grade serous ovarian or colorectal adenocarcinoma. We will investigate the feasibility of administering plerixafor in terms of safety, and will try to identify the proof of mechanism in patients. This study will follow the standard 3+3, Phase I trial design.
The purpose of this study is to find out if plerixafor has the same effect on patients with advanced pancreatic, ovarian or colorectal cancer, as we have seen in our laboratory experiments.
Patients will be given IV plerixafor continuously over 7 days via a PICC line (Peripherally Inserted Central Catheter). Each patient will need to stay in hospital for at least the initial 2 days (48 hours) whilst having the study drug infusion to ensure that the study drug is well tolerated. If the study drug is well tolerated, patients will be able to continue having the study drug at home, but will need to return daily for trial tests and for the infusion pump to be checked and changed. As part of this study, blood and tumour samples will be collected and analysed in our laboratories and, the cancer will be monitored using two imaging techniques (CT and FDG-PET scanning), continuous heart monitoring and standard clinical review assessments will be performed.
This study is being performed at Addenbrooke's Hospital, Cambridge and will recruit up to 28 patients.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0014
Date of REC Opinion
3 Mar 2015
REC opinion
Further Information Favourable Opinion