Vaccine Therapy for Patients With Stage III Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2004 by CancerVax Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
CancerVax Corporation
ClinicalTrials.gov Identifier:
NCT00052130
First received: January 22, 2003
Last updated: June 23, 2005
Last verified: September 2004
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052130

  Show 80 Study Locations
Sponsors and Collaborators
CancerVax Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00052130     History of Changes
Obsolete Identifiers: NCT00004130
Other Study ID Numbers: CV-MMAIT-3-001, JWCI-MC-3-001A
Study First Received: January 22, 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 August 26, 2014