Vaccine Therapy for Patients With Stage IV 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 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 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: Melanoma

Genetic and Rare Diseases Information Center resources: Carcinoid Tumor Neuroepithelioma

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 (Adult, Senior)
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

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: NCT00052156

Show 77 Study Locations

Sponsors and Collaborators

CancerVax Corporation

More Information

Additional Information:

CancerVax Corporation Website This link exits the ClinicalTrials.gov site

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

Hoshimoto S, Faries MB, Morton DL, Shingai T, Kuo C, Wang HJ, Elashoff R, Mozzillo N, Kelley MC, Thompson JF, Lee JE, Hoon DS. Assessment of prognostic circulating tumor cells in a phase III trial of adjuvant immunotherapy after complete resection of stage IV melanoma. Ann Surg. 2012 Feb;255(2):357-62. doi: 10.1097/SLA.0b013e3182380f56.


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

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

ClinicalTrials.gov processed this record on June 27, 2017

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