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Trial registered on ANZCTR


Registration number
ACTRN12605000442606
Ethics application status
Approved
Date submitted
5/08/2005
Date registered
21/09/2005
Date last updated
14/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase II trial of cellular immunotherapy on CA-125 response with M-FP cancer vaccine in patients with epithelial ovarian carcinoma
Scientific title
A Phase II trial of cellular immunotherapy on CA-125 response with M-FP cancer vaccine in patients with epithelial ovarian carcinoma
Secondary ID [1] 252211 0
Ovarian Cancer cellular immunotherapy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 554 0
Condition category
Condition code
Cancer 632 632 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 131 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 741 0
To determine whether cellular immunotherapy with M-FP cancer vaccine can lead to clinical responses or stabilisation of disease, as determined by serum CA-125, in patients with adenocarcinoma of the ovary.
Timepoint [1] 741 0
Measured from visit 5 onwards for each patient.
Secondary outcome [1] 1521 0
EFFICACY
- To estimate the duration of a CA-125 response or stabilisation.
- To estimate progression free survival (PFS), based on duration of CA-125 response or stabilisation.
- To determine whether treatment with M-FP cancer vaccine can lead to immunological responses in patients with adenocarcinoma of the ovary.
Timepoint [1] 1521 0
All secondary outcomes will be measured at the end of the trial for each patient.
Secondary outcome [2] 1522 0
SAFETY
- To further characterise the safety profile of M-FP cancer vaccine in patients with adenocarcinoma of the ovary.
Timepoint [2] 1522 0
All secondary outcomes will be measured at the end of the trial for each patient.
Secondary outcome [3] 1523 0
EXPLORATORY
- To evaluate the relationship between clinical response and CA-125 response in patients with measurable or non-measurable lesions
- To evaluate the rate of change in serum CA-125 levels before and during treatment with M-FP cancer vaccine.
- To evaluate the relationship between MUC1 expression on archival tissue samples and clinical response.
- To evaluate the relationship between histological subtype and clinical response.
- To evaluate the relationship between HLA type and immunological and CA-125 response.
Timepoint [3] 1523 0
All secondary outcomes will be measured at the end of the trial for each patient.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 691 0
Commercial sector/Industry
Name [1] 691 0
Commercial sponsor
Address [1] 691 0
see below
Country [1] 691 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cancer Vac Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 578 0
None
Name [1] 578 0
N/A
Address [1] 578 0
Country [1] 578 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1893 0
Austin Hospital
Ethics committee address [1] 1893 0
Victoria
Ethics committee country [1] 1893 0
Australia
Date submitted for ethics approval [1] 1893 0
Approval date [1] 1893 0
Ethics approval number [1] 1893 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35514 0
Address 35514 0
Country 35514 0
Phone 35514 0
Fax 35514 0
Email 35514 0
Contact person for public queries
Name 9320 0
Ms Effie Skrinos
Address 9320 0
Cancer Clinical Trials Centre
Austin Hospital
Austin Health
Level 3 Lance Townsend Building
145 - 163 Studley Road
Heidelberg VIC 3084
Country 9320 0
Australia
Phone 9320 0
+61 3 94963576
Fax 9320 0
Email 9320 0
Effie.Skrinos@ludwig.edu.au
Contact person for scientific queries
Name 248 0
Dr Emma Ball
Address 248 0
Cancer Vac Pty Ltd
Unit 7
79-83 High Street
Kew VIC 3101
Country 248 0
Australia
Phone 248 0
+61 3 98248166
Fax 248 0
Email 248 0
eball@primabiomed.com.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary