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Trial registered on ANZCTR


Registration number
ACTRN12608000355370
Ethics application status
Approved
Date submitted
6/06/2008
Date registered
24/07/2008
Date last updated
19/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase 1/2 study of immunotherapy of melanoma with dendritic cells pulsed with melanoma peptides or tumour extracts
Scientific title
A phase 1/2 study to evaluate the effects of autologous dendritic cell (DC) vaccine (+ or - Interleukin-2) on respomse in patients with malignant melanoma.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disseminated American Joint Committee on Cancer(AJCC ) Stage IV melanoma or locally recurrent melanoma. 3239 0
Melanoma 3376 0
Metastatic Melanoma 3387 0
Condition category
Condition code
Cancer 3525 3525 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.Patients (pts) are stratifed by Tissue Typing & then randomised into 2 groups, the two groups are Autologous Dendritric Cells (DC) alone or Autologous DC's plus Interleukin. (IL-2) will be self-administered by sub cutaneous(sc) injection on inner thighs or lower abdomen at a dose of 1 million units/m2/day commencing 2 days after each DC injection and continuing for 5 days after the first 3 DC injections and 12 days after the 4th DC injections and 14 days after the final 3 vaccines.DC vaccine injections will be given at week 0,1,2,3,5,9,& 13.All patients will complete a follow up at week 14. Patients will be equally allocated 2X2 to IL2. Patients will be required to have Computer Tomography (CT's) and Immunological blood examinations.DC are extracted from the patients blood.
Intervention code [1] 2979 0
Treatment: Other
Intervention code [2] 3185 0
Other interventions
Comparator / control treatment
Autologous Dendtric Cells (DC's) plus Interleukin-2
Control group
Active

Outcomes
Primary outcome [1] 4441 0
To determine whether DCs matured with a cytokine cocktail will be more effective at inducing immune and clinical responses to melanoma than DCs prepared without a maturation step.
This will be measeured by Computer Tomgraphy(CT) and Immunological blood examinations
Timepoint [1] 4441 0
Baseline and week 14
Secondary outcome [1] 7246 0
To evaluate whether low dose IL-2 given after each Dendtric Cell vaccine will increase immune and clinical responses to melanoma.This will be measured by Computer Tomography (CT's) and Immunological blood examinations.
Timepoint [1] 7246 0
Baseline and week 14
Secondary outcome [2] 7500 0
To determine whether clinical responses are more frequent in patients treated with Dendritic Cells plus peptides or Dendritic Cells plus autologous melanoma lysates, i.e. whether individual specific antigens may play a role in clinical responses.This will be measured by Computer Tomography (CT's) and Immunological blood examinations.
Timepoint [2] 7500 0
Baseline and week 14

Eligibility
Key inclusion criteria
1.Patients of either sex with histologically confirmed melanoma.
2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3.Non-resectable, low volume metastatic melanoma that is measurable and which has failed chemotherapy or where chemotherapy has not been recommended. Patients may be rendered low volume by partial surgical resection of their disease
Minimum age
17 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.No concomitant malignancy except for basal or squamous cell carcinoma of the skin or cone biopsied carcinoma of the cervix.
2.Chemotherapy or immunotherapy in the past four weeks or previous radiation therapy to target lesions.
3.Central Nervous System (CNS), spinal or bone metastases as the sole site of metastases.
4.Concomitant pregnancy.
5.Serum creatinine >15mmol/L or raised bilirubin due to melanoma.
6.Concomitant infections or other serious medical illness.
7.Concomitant steroid or other immunosuppressive therapy.
8.Other serious illness requiring therapy unrelated to cancer.
9. Patients who are Human immunodeficiency virus (HIV) positive, Hepatitis B sag, Hepatitis C positive. (All formally screened)
10. Patients with cardiac or pulmonary impairment assessed from history and Eloectrocardigram (ECG).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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)
1.Patients (pts) are stratifed by Tissue Typing 2. Patients will be randomised by equal allocation.2 pts will be randomised to il2 then 2 pts without il2
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
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)
NSW

Funding & Sponsors
Funding source category [1] 3574 0
Government body
Name [1] 3574 0
National Health & Medical Research Council
Address [1] 3574 0
Mallett St
Camperdown NSW 2050
Country [1] 3574 0
Australia
Primary sponsor type
Government body
Name
National Health & Medical Research Council
Address
Mallett St
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 3274 0
None
Name [1] 3274 0
Address [1] 3274 0
Country [1] 3274 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5616 0
Sydney South West Area Health Service
Ethics committee address [1] 5616 0
Royal Prince Alfred Hospital
Missenden Rd
Camperdown 2050
Ethics committee country [1] 5616 0
Australia
Date submitted for ethics approval [1] 5616 0
01/11/2002
Approval date [1] 5616 0
13/12/2002
Ethics approval number [1] 5616 0
No X02-0308:

Summary
Brief summary
Dendritic cells will be grown from metastatic melanoma patients' peripheral blood and used to present common tumour antigens (peptides) or tumour extracts as a vaccine. In addition, some patients will receive low dose IL-2 in addition to their vaccine. IL-2 has been shown to increase the life of cytotoxic lymphocytes generated in animal and human vaccines.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 28651 0
Address 28651 0
Country 28651 0
Phone 28651 0
Fax 28651 0
Email 28651 0
Contact person for public queries
Name 11808 0
Margaret Lett
Address 11808 0
Level 3 Gloucester House
RPA
Missenden Rd Camperdown NSW 2050
Country 11808 0
Australia
Phone 11808 0
0299117304
Fax 11808 0
029954 9435
Email 11808 0
margaret.lett@smu.org.au
Contact person for scientific queries
Name 2736 0
Professor Peter Hersey
Address 2736 0
Cnr King & Watt Sts
Newcastle NSW2300
Country 2736 0
Australia
Phone 2736 0
0249 236 828
Fax 2736 0
Email 2736 0
peter.hersey@newcastle.edu.au

No information has been provided regarding IPD availability
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