Vaccine Therapy in Treating 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. Identifier: NCT00042783
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine therapy may be effective in treating stage IV melanoma.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: D1/3-MAGE-3-His fusion protein Biological: SB-AS02B adjuvant Phase 2

Detailed Description:


  • Determine the feasibility of treating patients with stage IV melanoma with D1/3-MAGE-3-His fusion protein with SB-AS02B adjuvant.
  • Determine the clinically confirmed response rates (partial and complete responses) of patients treated with this regimen.
  • Determine the 6-month progression-free survival rate of patients treated with this regimen.
  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.
  • Determine immune responses in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive D1/3-MAGE-3-His fusion protein emulsified in SB-AS02B adjuvant intramuscularly once every 3 weeks for a total of 12 weeks (4 injections). In the absence of disease progression or unacceptable toxicity, patients receive a second 12-week course beginning at week 16.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of A D1/3-MAGE3-HIS Fusion Protein (NSC-719274) With Adjuvant SBAS02B (NSC-719275) For Patients With Stage IV, M1a or M1b Metastatic Melanoma
Study Start Date : September 2002
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed stage IV melanoma that is considered incurable by surgery, radiotherapy, or limb perfusion

    • M1a or M1b disease
  • Measurable disease outside prior field of limb perfusion
  • Metastatic mucosal melanoma allowed
  • MAGE-3 positive by reverse transcription polymerase chain reaction
  • No uveal or choroidal primary melanoma
  • No prior or concurrent brain metastases by CT scan or MRI of the brain



  • Not specified

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • Not specified


  • Hepatitis B surface antigen negative
  • Hepatitis C negative
  • No liver cirrhosis
  • No unstable liver disease
  • No coagulation disorders


  • Not specified


  • No major cardiovascular illness
  • No myocardial infarction within the past 6 months


  • No major pulmonary illness


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No AIDS or HIV-1-associated complex
  • No chronic alcohol abuse or drug addiction
  • No systemic infections
  • No prior active autoimmune disease
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently disease-free


Biologic therapy

  • At least 4 weeks since prior adjuvant biologic therapy
  • No prior biologic therapy for stage IV melanoma
  • No prior MAGE-3 peptide or protein vaccine preparation


  • At least 4 weeks since prior adjuvant chemotherapy
  • No prior chemotherapy for stage IV melanoma

Endocrine therapy

  • Not specified


  • At least 4 weeks since prior adjuvant radiotherapy


  • At least 4 weeks since prior surgery


  • See Disease Characteristics
  • At least 3 weeks since prior limb perfusion and recovered
  • At least 4 weeks since other prior adjuvant therapy
  • No other prior therapy for stage IV melanoma

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): NCT00042783

United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Mississippi
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States, 39531-2410
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98195-6527
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Jeffrey S. Weber, MD, PhD University of Southern California Identifier: NCT00042783     History of Changes
Other Study ID Numbers: CDR0000069468
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: April 2004

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas