Cancer, Neoplasms
Conditions
Keywords
Pancreatic, Late stage cancer, Immunotherapy, Phase I, Vaccination
Brief 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.
Detailed description
The immune system has an important role in helping prevent cancer by destroying early cancer cells. When cancer does develop antigen-specific immune (T) cells are still present in the blood but are either not responding or are not effective. Vaccines stimulate these T cells to respond and kill cancer cells. ACIT-1 is designed to stimulate tumour antigen-specific T cells to respond and kill cancer cells.
Interventions
BIOLOGICALACIT-1
Cell suspension
Sponsors
Cancer Vaccines Limited
Liverpool University Hospitals NHS Foundation Trust
The Clatterbridge Cancer Centre NHS Foundation Trust
University of Liverpool
Cancer Research UK
National Institute for Health Research, United Kingdom
Cancer Vaccines Charitable Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 treatment with the exception of standard of care chemotherapy for pancreatic and haematological cancer patients * Participation in another investigational medicinal product trial within 28 days of treatment * Other vaccination within previous 4 weeks * Antibody treatment within previous 3 months * Major surgery within the 14 days preceding the screening visit * Scheduled elective surgery or other procedures requiring general anaesthesia during the study * Allogeneic graft transplantation recipient * Active systemic autoimmune and allergic disease * Pregnant or lactating females * Significant renal or hepatic impairment as defined by the following: Serum creatinine ≥ 1.5 x upper limit of normal and/or GFR ≤ 40 ml/min. Total bilirubin ≥ 1.5 x upper limit of normal; and AST/ALT ≥ 5 x upper limit of normal * Life threatening illness unrelated to the patient's cancer * Previous history of serious adverse allergic reaction to any medication * Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | From start of treatment to 20 weeks. | Toxicity based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical benefit | From start of treatment up to 14 months. | Survival time |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORDaniel H Palmer, MBChB PhD
Clatterbridge Cancer Centre
Outcome results
None listed