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Vaccine Therapy in Treating Patients With Malignant 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. Identifier: NCT00128583
Recruitment Status : Unknown
Verified September 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 10, 2005
Last Update Posted : December 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: polyvalent melanoma vaccine Phase 2

Detailed Description:


  • Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™).

OUTLINE: This is an open-label, multicenter study.

Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of response at week 24 receive no further treatment. Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine (Canvaxin™).

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Primary Outcome Measures :
  1. Response

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.

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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


  • Histologically confirmed malignant melanoma
  • At least 1 in-transit skin lesion measuring 3-10 mm in the longest diameter



  • 18 to 80

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

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 identifier (NCT number): NCT00128583

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United States, California
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States, 92262
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, United States, 90404
United States, Florida
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States, 33804-1057
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Ohio
CCOP - Dayton
Dayton, Ohio, United States, 45429
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
Australia, New South Wales
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Sponsors and Collaborators
CancerVax Corporation
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Study Chair: Linda Strause CancerVax Corporation
Layout table for additonal information Identifier: NCT00128583    
Other Study ID Numbers: CDR0000439529
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: September 2005
Keywords provided by National Cancer Institute (NCI):
stage III melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas