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Vaccine Therapy for Patients With Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00052156
Recruitment Status : Unknown
Verified April 2005 by CancerVax Corporation.
Recruitment status was:  Active, not recruiting
First Posted : January 24, 2003
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
CancerVax Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Biological: CancerVax vaccine (CANVAXIN) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052156


Locations
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Sponsors and Collaborators
CancerVax Corporation
More Information
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Additional Information:

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

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ClinicalTrials.gov Identifier: NCT00052156    
Obsolete Identifiers: NCT00003722
Other Study ID Numbers: CV-MMAIT-4-001
JWCI-MC-4-001
First Posted: January 24, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2005
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas