Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000450415
Ethics application status
Approved
Date submitted
26/06/2007
Date registered
31/08/2007
Date last updated
26/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I Clinical Trial of a Christchurch Medical Research Foundation (CMRF)-56+ Blood Dendritic Cell Preparation for the Immunotherapy of Metastatic Hormone Refractory Prostate Cancer
Scientific title
A Phase I Clinical Trial of a Christchurch Medical Research Foundation (CMRF)-56+ Blood Dendritic Cell Preparation for the Immunotherapy of Metastatic Hormone Refractory Prostate Cancer
Secondary ID [1] 252958 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
MMRI#CT3-PC-CMRF-56BDC-02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with hormone refractory metastatic prostate cancer 2170 0
Condition category
Condition code
Cancer 2265 2265 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a phase I, dose-finding study of CMRF-56 Blood Dendritic Cell (BDC)-02 vaccination. Twelve patients, from whom the vaccine can successfully be produced, will be recruited. Initially, three subjects will receive three doses of 1x106 CMRF-56+ Blood Dendritic Cell (BDC), given into the skin (intra-dermal) at monthly intervals. When all three subjects have safely received their second dose of CMRF-56 lood Dendritic Cell (BDC)- 02, a further three subjects will be recruited to receive three doses of 1x107CMRF-56+ Blood Dendritic Cell (BDC), also given into the skin at monthly intervals. When all of these subjects have received their second dose safely, six additional subjects will commence the same protocol as above, however they will receive their vaccines through the veins (intravenously).
Intervention code [1] 1854 0
Treatment: Drugs
Comparator / control treatment
There is no control arm to this study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3285 0
Safety analysis by tabulation of subjects with adverse events by severity and relation to CMRF-56BDC-02 administration. Examples of adverse events include anaphylaxis, shortness of breath, increase in temperature (fever), tachycardia, blood pressure laterations outside normal range, and pain at administration site
Timepoint [1] 3285 0
Baseline and within 2 hours of adminsitration of vaccine
Secondary outcome [1] 5465 0
Immunological eficacy will be measure by performing immunological assays, CTL responses, Eliza and clinical efficacy which will be measured by PSA values, CT scan and Bone scan reports
Timepoint [1] 5465 0
Baseline, + 1 month, + 2 months, + 3 months and day 133

Eligibility
Key inclusion criteria
1) Histologically documented adenocarcinoma of the prostate any Gleason Score, confirmed by the Mater Health Services Pathology prior to registration.
2) Metastatic, androgen independent adenocarcinoma of the prostate. Metastatic disease is defined by soft tissue and/or bony metastases on imaging or pathological studies (Computed Tomography, bone scan or histology). Androgen independent adenocarcinoma of the prostate is defined by a rising serum Prostate Specific Antigen (PSA) level confirmed on two consecutive PSA values, at least 28 days apart, each ?6.5ng/mL using the Architect method, and = 50% above the minimum PSA observed during castration therapy or = 50% above the pretreatment value if there was no response to androgen deprivation therapy. At least one serum PSA estimation must be conducted by Mater Health Services Pathology.
3) Adequate androgen suppression as evidenced by a serum testosterone level ?50ng/dL.
4) Life expectancy of at least 6 months.
5) Age 18-80 years.
6) Performance status Eastern Cooperatic Oncology Group ?2
(7) Adequate haematological reserve for apheresis and dendritic cell preparation as defined by:
I. Neutrophils > 1.8x109/L.
II. Lymphocytes > 1x109/L.
III. Haemoglobin > 110g/L.
IV. Platelets > 150x109/L.
8) HLA-A*0201 positive.
9) Written informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) Intercurrent participation in another clinical trial of Prostate Cancer therapy.
Justified as outcomes and adverse events may be attributed to either therapy.
2) Known brain metastasis or spinal cord compression.
Justified as inflammation in these critical sites is a possibility and patient safety is paramount. Also these conditions require specific intervention which influences interpretation of data collected. They also carry poor prognostic implications, which may affect ability of the patient to complete the trial.
3) Significant bony metastatic disease involving axial skeleton with risk of spinal cord compression or pathological fracture.
Justified as these conditions require specific intervention which influences interpretation of data collected. They also carry poor prognostic implications, which may affect ability of the patient to complete the trial.
4) Progressive metastatic disease, as defined as increasing symptoms requiring change in medication within the previous 4 weeks.
Justified as disease progression requiring change in medication carries prognostic implications which influences ability of patients to complete the trial. Also, new medication may have side effects which could not be distinguished from adverse events.
5) Treatment with chemotherapy, bisphosphonate therapy, external beam radiation therapy, surgery, systemic corticosteroids, megestrol acetate, diethylstilboestrol (DES), ketoconazole, 5-alpha-reductase inhibitors, calcitriol, Interferon or other immunomodulatory medication, strontium, or any other systemic therapy for prostate cancer within 28 days of registration (excluding androgen deprivation therapy).
Justified as disease requiring these treatments is advanced with poor prognosis, or the treatments themselves are likely to have side effects which could not be distinguished from adverse events due to the trial vaccine.
6) Receipt of investigational vaccine within 1 year of registration.
Justified as it would not be possible to determine which vaccine adverse events could be attributed to.
7) Receipt of any other investigational product within 28 days of registration.
Justified as it would not be possible to determine which investigational product adverse events could be attributed to.
8) Antibiotic therapy or infection within 1 week prior to registration, including unexplained fever (temp greater than 100.5 F or 38.1 C).
Justified as current or partially treated infection is a contraindication to vaccination.
9) No vaccinations against infectious disease, including influenza vaccine, in the three months prior to and during the trial.
Justified as recent vaccination may effect trial vaccine efficacy, or interact with the trial vaccine.
10) Intercurrent medical, surgical or psychiatric condition, which, in the opinion of the medical monitor, may interfere with the conduct or safety of the trial.
Justified as patient safety is paramount.
11) Positivity for humn immunodeficiency virus 1/2, human T cell lymphotropic virus 1/2, Hepatitis B, Hepatitis C or Syphilis (VDRL).
Justified as these conditions cause immunosuppression which may impact on trial vaccine efficacy.

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 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 393 0
4101

Funding & Sponsors
Funding source category [1] 2544 0
Government body
Name [1] 2544 0
US Department of Defence
Country [1] 2544 0
United States of America
Primary sponsor type
Other
Name
Mater Medical Research Institute
Address
Level 3 Aubigny Place Raymond Terrace,
South Brisbane Q 4101
Country
Australia
Secondary sponsor category [1] 2302 0
Hospital
Name [1] 2302 0
Mater Health Services
Address [1] 2302 0
Raymond Terrace South Brisbane Q 4101
Country [1] 2302 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4460 0
Mater Health Services
Ethics committee address [1] 4460 0
Ethics committee country [1] 4460 0
Australia
Date submitted for ethics approval [1] 4460 0
21/04/2005
Approval date [1] 4460 0
31/08/2005
Ethics approval number [1] 4460 0
MHS 852A

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

Contacts
Principal investigator
Name 27668 0
Address 27668 0
Country 27668 0
Phone 27668 0
Fax 27668 0
Email 27668 0
Contact person for public queries
Name 11043 0
Georgina Crosbie
Address 11043 0
Level 3 Aubigny Place
Raymond Terrace
South Brisbane QLD 4101
Country 11043 0
Australia
Phone 11043 0
07 3840 3484
Fax 11043 0
07 3840 2134
Email 11043 0
gcrosbie@mmri.mater.org.au
Contact person for scientific queries
Name 1971 0
Professor Derek Hart
Address 1971 0
Level 3 Aubigny Place
Raymond Terrace
South Brisbane QLD 4101
Country 1971 0
Australia
Phone 1971 0
07 3840 2555
Fax 1971 0
07 3840 2550
Email 1971 0
dhart@mmri.mater.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.