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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00052130




Registration number
NCT00052130
Ethics application status
Date submitted
22/01/2003
Date registered
24/01/2003
Date last updated
24/06/2005

Titles & IDs
Public title
Vaccine Therapy for Patients With Stage III Melanoma
Scientific title
Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With BCG Plus a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Versus BCG Plus a Placebo as a Post-Surgical Treatment for Stage III Melanoma
Secondary ID [1] 0 0
JWCI-MC-3-001A
Secondary ID [2] 0 0
CV-MMAIT-3-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CancerVax vaccine (CANVAXIN)

Other interventions: CancerVax vaccine (CANVAXIN)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Must have Stage III 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
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,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital, Sydney - Sydney
Recruitment hospital [2] 0 0
NSW Breast Cancer Institute - Westmead
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3002 - Melbourne
Recruitment postcode(s) [6] 0 0
3181 - Melbourne
Recruitment outside Australia
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Arizona
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Arkansas
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California
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Utah
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United States of America
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Washington
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Canada
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Quebec
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France
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Paris
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Germany
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Augsburg
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Germany
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Berlin
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Germany
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Jena
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Germany
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Mannheim
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Germany
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Tuebingen
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Germany
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Ulm
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Germany
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Wuerzburg
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Ireland
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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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Milan
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Italy
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Naples
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Netherlands
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Groningen
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New Zealand
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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

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CancerVax Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage
III), 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00052130
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00052130