None listed
Conditions
Interventions
This is a single centre, non comparative, open label, single arm phase II study. The study will evaluate intradermal injection of autologous dendritic cells cultured ex vivo with M-FP Cancer vaccine comprising a portion (VNTR Region) of the MUC 1 protein fused to glutathione-S-transferase (GST) and conjugated to polymannose. M-FP is delivered to the patient as vaccine loaded dendritic cells, three injections over a 10 week period, followed by booster injections every ten weeks for a total of s
This is a single centre, non comparative, open label, single arm phase II study. The study will evaluate intradermal injection of autologous dendritic cells cultured ex vivo with M-FP Cancer vaccine comprising a portion (VNTR Region) of the MUC 1 protein fused to glutathione-S-transferase (GST) and conjugated to polymannose. M-FP is delivered to the patient as vaccine loaded dendritic cells, three injections over a 10 week period, followed by booster injections every ten weeks for a total of seven treatments over 12 months. The aim will be to readminister a minimum of 25 x 106 M-FP loaded dendritic cells at each reinjection, into 6 to 8 sites.
Sponsors
Cancer Vac Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically or cytologically proven epithelial adenocarcinoma of ovarian or fallopian tube origin, or primary peritoneal carcinoma. - No options for curative therapy. - Rising CA-125, which is defined as an increase in CA-125 by at least 25% from a baseline reading within one month. A repeat CA-125 test must be done to confirm the increased value. At least one level must be greater than or equal to twice the upper limit of the normal range (ULNR). - No surgery, radiotherapy, chemotherapy, hormonal therapy for malignancy, immunotherapy or experimental therapy within the last 4 weeks. - Adequate bone marrow function (white blood cells >3.0 x 109 per litre, haemoglobin > 100 g/L, platelets >100 x 109 per litre). - Adequate liver function (bilirubin < 2 x ULNR, AST or ALT < 5 x ULNR). - Adequate renal function (creatinine within normal ranges). - At least 18 years of age. - Life expectancy of at least 6 months. - ECOG Performance Status of 0 - 1 inclusive (Ambulatory and able to carry out activities of daily living). - Written informed consent given by the patient.
Exclusion criteria
Coexisting or previous other malignancies unless in complete remission for not less than 2 years and excepting in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin. - Ovarian sarcoma / mixed Mullerian tumours. - Active uncontrolled infections. - Psychiatric, addictive or any (medical) disorder which compromises ability to give truly informed consent for participation in this study or comply with the requirements of the study. - Any serious medical condition that may prevent the participant from completing at least the first six months of the study. - Concurrent systemic steroid treatment. - Clinical autoimmune disease, eg rheumatoid arthritis, systemic lupus erythematosus, (except autoimmune thyroiditis). - Clinically significant ischaemic heart disease (unstable angina or acute myocardial infarction within the last 3 months) or cardiac failure (NYHA Class III or IV) - see Appendix A. - Infection with the Human Immunodeficiency (AIDS) Virus, hepatitis B virus or hepatitis C virus. - Pregnant or breast feeding, or planning to become pregnant during the course of the study. - Evidence of CNS metastases.
Outcome results
None listed