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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00052156
Registration number
NCT00052156
Ethics application status
Date submitted
23/01/2003
Date registered
24/01/2003
Date last updated
24/06/2005
Titles & IDs
Public title
Vaccine Therapy for Patients With Stage IV Melanoma
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Scientific title
A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Plus BCG Versus Placebo Plus BCG as a Post-Surgical Treatment for Stage IV Melanoma
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Secondary ID [1]
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JWCI-MC-4-001
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Secondary ID [2]
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CV-MMAIT-4-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malignant Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
* Must have Stage IV melanoma
* Must have had all clinically-detectable disease surgically removed
* Cannot be taking any medications, or undergoing any therapies which compromise the functioning of your immune system (ie. Some corticosteroids, and certain types of radiation therapy)
* Cannot have HIV or Hepatitis A, B, or C
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Minimum age
18
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
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Actual
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Actual
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Sample size
Target
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital, Sydney - Sydney
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NSW Breast Cancer Institute - Westmead
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Princess Alexandra Hospital - Brisbane
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Royal Adelaide Hospital - Adelaide
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Peter MacCallum Cancer Center - Melbourne
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2050 - Sydney
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4102 - Brisbane
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3002 - Melbourne
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Recruitment postcode(s) [6]
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3181 - Melbourne
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Recruitment outside Australia
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Arizona
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Brazil
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Rio de Janeiro
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Brazil
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Augsburg
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Berlin
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Jena
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Mannheim
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Tuebingen
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Germany
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Ulm
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Wuerzburg
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Cork
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Israel
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Tel Aviv
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Italy
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Italy
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Naples
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Groningen
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Auckland
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Switzerland
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Zurich
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United Kingdom
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England
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
CancerVax Corporation
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.
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Trial website
https://clinicaltrials.gov/study/NCT00052156
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Trial related presentations / publications
Faries MB, Mozzillo N, Kashani-Sabet M, Thompson JF, Kelley MC, DeConti RC, Lee JE, Huth JF, Wagner J, Dalgleish A, Pertschuk D, Nardo C, Stern S, Elashoff R, Gammon G, Morton DL; MMAIT-IV Clinical Trial Group. Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Ann Surg Oncol. 2017 Dec;24(13):3991-4000. doi: 10.1245/s10434-017-6072-3. Epub 2017 Oct 10. Hoshimoto S, Faries MB, Morton DL, Shingai T, Kuo C, Wang HJ, Elashoff R, Mozzillo N, Kelley MC, Thompson JF, Lee JE, Hoon DS. Assessment of prognostic circulating tumor cells in a phase III trial of adjuvant immunotherapy after complete resection of stage IV melanoma. Ann Surg. 2012 Feb;255(2):357-62. doi: 10.1097/SLA.0b013e3182380f56.
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00052156
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