Vaccine Therapy for Patients With Stage III Melanoma - Tabular View

Tracking Information
First Received Date ^ICMJE	January 22, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00052130 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Vaccine Therapy for Patients With Stage III Melanoma
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Malignant Melanoma
Intervention ^ICMJE	Biological: CancerVax vaccine (CANVAXIN)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	1118
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Brazil, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Switzerland, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00052130
Responsible Party
Study ID Numbers ^ICMJE	CV-MMAIT-3-001, JWCI-MC-3-001A
Study Sponsor ^ICMJE	CancerVax Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	CancerVax Corporation
Verification Date	September 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP