Vaccine Therapy for Patients With Stage IV Melanoma

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

Verified April 2005 by CancerVax Corporation.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

CancerVax Corporation

ClinicalTrials.gov Identifier:

NCT00052156

First received: January 23, 2003

Last updated: June 23, 2005

Last verified: April 2005

History of Changes

Tracking Information
First Received Date ^ICMJE	January 23, 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 NCT00052156 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Vaccine Therapy for Patients With Stage IV Melanoma
Official Title ^ICMJE	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
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.
Detailed Description
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)
Publications *	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.
* 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	670
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
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	NCT00052156
Other Study ID Numbers ^ICMJE	CV-MMAIT-4-001, JWCI-MC-4-001
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	CancerVax Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	CancerVax Corporation
Verification Date	April 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top