Vaccine Therapy for Patients With Stage III Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2004 by CancerVax Corporation.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

CancerVax Corporation

ClinicalTrials.gov Identifier:

NCT00052130

First received: January 22, 2003

Last updated: June 23, 2005

Last verified: September 2004

History of Changes

Tracking Information
First Received Date ^ICMJE	January 22, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00052130 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Malignant Melanoma
Intervention ^ICMJE	Biological: CancerVax vaccine (CANVAXIN)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	1118
Completion Date	Not Provided
Primary Completion Date	Not Provided
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 Number ^ICMJE	NCT00052130
Other Study ID Numbers ^ICMJE	CV-MMAIT-3-001, JWCI-MC-3-001A
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	CancerVax Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
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

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