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Vaccine Therapy for Patients With Stage III Melanoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2004 by CancerVax Corporation.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00052130
First Posted: January 24, 2003
Last Update Posted: December 9, 2005
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.
Information provided by:
CancerVax Corporation
  Purpose
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.

Condition Intervention Phase
Malignant Melanoma Biological: CancerVax vaccine (CANVAXIN) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by CancerVax Corporation:

Estimated Enrollment: 1118
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
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): NCT00052130


  Show 80 Study Locations
Sponsors and Collaborators
CancerVax Corporation
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00052130     History of Changes
Obsolete Identifiers: NCT00004130
Other Study ID Numbers: CV-MMAIT-3-001
JWCI-MC-3-001A
First Submitted: January 22, 2003
First Posted: January 24, 2003
Last Update Posted: December 9, 2005
Last Verified: September 2004

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs