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

First Received on January 23, 2003. Last Updated on June 23, 2005 History of Changes

Sponsor:	CancerVax Corporation
Information provided by:	CancerVax Corporation
ClinicalTrials.gov Identifier:	NCT00052156

Purpose

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.

Condition	Intervention	Phase
Malignant Melanoma	Biological: CancerVax vaccine (CANVAXIN)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Canvaxin

U.S. FDA Resources

Further study details as provided by CancerVax Corporation:

Estimated Enrollment:

670

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052156

Show 77 Study Locations

Sponsors and Collaborators

CancerVax Corporation

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00052156 History of Changes
Obsolete Identifiers:	NCT00003722
Other Study ID Numbers:	CV-MMAIT-4-001, JWCI-MC-4-001
Study First Received:	January 23, 2003
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on February 12, 2012