Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or 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: NCT00006113
Recruitment Status : Terminated (Lack of efficacy)
First Posted : January 27, 2003
Last Update Posted : May 22, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

August 3, 2000
January 27, 2003
May 22, 2014
June 1999
May 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006113 on Archive Site
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Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
A Phase II Trial of a MART-1/gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated With CD40 Ligand/Gamma Interferon With Subcutaneous IL-2 for Patients With Metastatic Melanoma

RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.


  • Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in vivo.
  • Determine the toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4, sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24 months.

Phase 2
Primary Purpose: Treatment
Melanoma (Skin)
  • Biological: MART-1 antigen
  • Biological: aldesleukin
  • Biological: gp100 antigen
  • Biological: recombinant CD40-ligand
  • Biological: recombinant interferon gamma
  • Biological: recombinant interleukin-4
  • Biological: sargramostim
  • Biological: therapeutic autologous dendritic cells
  • Biological: therapeutic tumor infiltrating lymphocytes
  • Biological: tyrosinase peptide
  • Radiation: Candida albicans skin test reagent
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2006
May 2003   (Final data collection date for primary outcome measure)


  • Histologically confirmed metastatic melanoma

    • Measurable disease after attempted curative surgery
    • Unresectable stage III or IV uveal melanoma
    • Metastatic mucosal melanoma
  • HLA-A2.1 positive
  • No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg every 8 hours)



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • WBC at least 3,000/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 9.0 g/dL
  • No coagulation disorders


  • Bilirubin no greater than 2.0 mg/dL


  • Creatinine no greater than 2.0 mg/dL


  • No myocardial infarction within the past 6 months
  • Patients with documented or suspected coronary artery disease must undergo stress thallium test
  • No major cardiovascular illness


  • No major pulmonary illness


  • HIV negative
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative
  • No history of uveitis or autoimmune inflammatory eye disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No major systemic infection
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer


Biologic therapy:

  • See Disease Characteristics
  • No prior MART-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens


  • At least 1 month since prior chemotherapy for melanoma

Endocrine therapy:

  • No concurrent steroid therapy


  • At least 1 month since prior radiotherapy for melanoma


  • See Disease Characteristics


  • At least 1 month since prior adjuvant therapy for melanoma
  • At least 1 month since other prior therapy for melanoma
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000068125 (10M-99-1)
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University of Southern California
University of Southern California
National Cancer Institute (NCI)
Study Chair: Jeffrey S. Weber, MD, PhD University of Southern California
University of Southern California
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP