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Trial registered on ANZCTR


Registration number
ACTRN12608000174381
Ethics application status
Approved
Date submitted
12/02/2008
Date registered
9/04/2008
Date last updated
21/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study of dendritic cell vaccination for stage IV melanoma following combination lymphodepleting chemotherapy.
Scientific title
A pilot study of dendritic cell (DC) vaccination using DCs pulsed with cell derived tumour antigen for stage IV melanoma following immune modulatory doses of chemotherapy to determine safety and tolerability.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage IV Melanoma 2826 0
Condition category
Condition code
Cancer 2959 2959 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cyclophosphamide oral 200mg/day for 28 days,
8 x Tumour-pulsed dendritic cells (up to 6 x10E6 cells per injection) given intradermally at 2 weekly intervals.
Intervention code [1] 2559 0
Treatment: Other
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3838 0
The primary outcome of this study will be the safety and tolerability profile of combination immunodepleting chemotherapy and immunotherapy with autologous or allogeneic tumour pulsed DC. Safety and tolerability will be assessed using the national Cancer Institute Common Termionology Criteria for Adverse Events v3.0 (CTCAE)
Timepoint [1] 3838 0
Day 0, 7, 14, 21, weeks 4, 6, 8, 10, 12, 14, 16, 18.
Secondary outcome [1] 6466 0
Disease response will be documented using Response Evaluation Criteria in Solid Tumour (RECIST criteria) to provide preliminary clinical information on efficacy of study therapy
Timepoint [1] 6466 0
Day0, week 4, 10, 18

Eligibility
Key inclusion criteria
All subjects
1. Patients with metastatic stage IV metastatic melanoma not curable with standard therapy (radiotherapy or chemotherapy) and/or in whom standard therapy does not have proven survival benefits. This is relevant to the clinical state of the patient at the time of enrolment.
2. Written informed consent
3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (see Appendix 2)
4. Subject judged to be able to safely undergo leukapheresis
5. Age > 16.
6. Life expectancy estimated to be greater than 4 months
Minimum age
16 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any concurrent therapy with possible activity against the patient’s malignancy with the exception of aminobisphosphonates
(local radiotherapy on lesions not essential for study evaluation is allowed)
2. Concurrent therapy with any agent known to have immune modulating activity
3. Any therapy with possible activity against the patient’s malignancy in the month preceding administration of first dose of study therapy
4. Patient unable to undergo leukapheresis due to serious co-existing medical conditions
(particularly cardiac or cardiovascular) or for other reasons
5. ECOG > 2
6. Pregnant or breast feeding or at risk for becoming pregnant within 3 months of enrolment
7. HIV, Hepatitis B or Hepatitis C positive
8. Patients who need immediate therapy because of a disease related complication or in whom a complication is predicted on clinical suspicion, and for whom some standard therapy is available and appropriate in the clinical condition. This does not apply to disease symptoms for which non disease specific therapy (e.g. analgesia) would be routinely offered. Patients excluded because of these criteria can become eligible after the immediate medical need has been fully treated with standard therapy and one month has elapsed.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
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)
QLD

Funding & Sponsors
Funding source category [1] 3082 0
Self funded/Unfunded
Name [1] 3082 0
Address [1] 3082 0
Country [1] 3082 0
Funding source category [2] 3273 0
University
Name [2] 3273 0
University of Queensland
Address [2] 3273 0
St Lucia, Queensland, Australia
Country [2] 3273 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia, Brisbane
Country
Australia
Secondary sponsor category [1] 2776 0
None
Name [1] 2776 0
Address [1] 2776 0
Country [1] 2776 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The proposed research involves combining immunodepleting and immune modulatory chemotherapy with tumour specific immune therapy involving autologous dendritic cells.
Hypothesis:
1. Pre-treatment with immunodepleting chemotherapy reduces the regulatory T-cell population
2. Reduction of regulatory T cell population augments the anticancer activities of immune therapy with DCs

The aim of this pilot study is to provide information on the safety and tolerability of this regimen in patients with advanced melanoma whilst obtaining immunological data crucial to the design of larger studies evaluating this approach. We also hope to obtain preliminary information on whether pretreating patients with lymphodepleting chemotherapy augments the anticancer activities of immune therapy with DCs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28369 0
Address 28369 0
Country 28369 0
Phone 28369 0
Fax 28369 0
Email 28369 0
Contact person for public queries
Name 11526 0
Sharon Senini
Address 11526 0
Centre for Immune and Targeted Therapy
Greenslopes Private Hospital\
Greenslopes 4120
Country 11526 0
Australia
Phone 11526 0
07 3394 7074
Fax 11526 0
Email 11526 0
seninis@ramsayhealth.com.au
Contact person for scientific queries
Name 2454 0
A/Prof Andrew Nicol
Address 2454 0
Centre for Immune and Targeted Therapy
Greenslopes Private Hospital\
Greenslopes 4120
Country 2454 0
Australia
Phone 2454 0
07 33241233
Fax 2454 0
Email 2454 0
anic9909@bigpond.net.au

No information has been provided regarding IPD availability
Summary results
No Results