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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
  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 3

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
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 by CancerVax Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 May 16, 2013