Investigation of a Therapeutic Vaccine (ACIT-1) in Cancer (NCT03096093) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Investigation of a Therapeutic Vaccine (ACIT-1) in Cancer
United Kingdom34 participantsStarted 2017-04-25
Plain-language summary
This study evaluates four different doses of ACIT-1 for safety and for the ability to raise effective anti-cancer immune responses in patients with pancreatic and other cancers. Approximately half of the patients will have pancreatic cancer and the other half will have other cancers.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed malignancy
* Life-expectancy of 3 months or greater
* Aged 18 years or above
* Willing and able to give written informed consent for participation in the study
* Eastern Cooperative Oncology Group performance status of 0,1,2.
* Absolute neutrophil count of ≥ 1 x 10e12/m3
* Platelet count of at least 70 x 10e12/m3
* Total bilirubin \< 1.5x upper limit of normal; and aspartate transaminase/alanine transaminase (AST/ALT) \< 5x upper limit of normal
* Creatinine \< 1.5x upper limit of normal and/or glomerular filtration rate (GFR) \> 40ml/min
* Female patients of child bearing potential and male patients whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
* Normal ECG measurements
* Able (in the Investigators opinion) and willing to comply with all study requirements
* Willing to allow his or her General Practitioner (GP) and consultant, if appropriate, to be notified of participation in the study, and for the GP and/or the National Cancer Registry to be contacted during follow up after the end of treatment.
Exclusion Criteria:
* Concurrent use of immunosuppressive drugs, in particular systemic steroid therapy, above a threshold of 10mg per day prednisolone equivalent
* Evidence of active infection e.g. Hepatitis B, Hepatitis C, HIV or syphilis
* Chemotherapy, radiotherapy or biological therapy within 28 days of tr…