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Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

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ClinicalTrials.gov Identifier: NCT00053391
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : May 12, 2015
Information provided by (Responsible Party):
PD Dr. med. univ. Beatrice Schuler-Thurner, University Hospital Erlangen

Brief Summary:

RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.

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

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: recombinant CD40-ligand Biological: therapeutic autologous dendritic cells Phase 1 Phase 2

Detailed Description:


  • Compare the efficacy of vaccination with autologous dendritic cells pulsed with tumor and influenza antigen peptides treated with vs without ex vivo CD40-ligand, in terms of tumor-specific T-cell response, in patients with HLA-A1 and/or HLA-A2.1 positive stage III or IV melanoma.
  • Determine the safety and tolerability of these vaccinations in these patients.
  • Determine tumor response and recurrence rates in patients treated with these vaccinations.

OUTLINE: This is an open-label non-randomized study.

  • Phase I: Patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMC). PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 to generate dendritic cells (DCs) on day -9. DCs are pulsed separately with HLA-A1 and HLA-A2.1-restricted flu matrix peptides derived from melanoma-associated tumor antigens (MAGE-10.A2, Melan-A, MAGE-3, NY-ESO-1, gp100 antigen, and tyrosinase peptide). Half of the DCs are treated ex vivo with CD40-ligand. Patients receive the peptide-pulsed DC vaccinations subcutaneously (SC) on days 1, 14, 42, and 70 in the absence of disease progression.

Patients who show tumor response (at least stable disease) at day 98 progress to phase II of the study.

  • Phase II: Patients undergo leukapheresis as in phase I on days 102, 352, and 688. Patients receive up to 6 additional booster vaccinations SC as in phase I on days 126, 184, 268, 356, 520, and 692.

Patients are followed for 10 years.

PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccination Of HLA-A1 And/Or -A2+ Stage III or IV Melanoma Patients With Tumor Peptide - Loaded Autologous Dendritic Cells That Are Generated In The Absence Or Presence Of CD40 Ligand
Study Start Date : October 2002
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma Vaccines

Primary Outcome Measures :
  1. Comparison of the efficacy of vaccination with vs without ex vivo CD40-ligand in terms of tumor-specific T-cell response
  2. Safety
  3. Tolerability

Secondary Outcome Measures :
  1. Tumor response
  2. Recurrence rates

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed stage III or IV cutaneous malignant melanoma
  • HLA-A1 and/or HLA-A2 expression by serologic HLA typing

    • HLA-A2.1 subtype must be confirmed by polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells
  • No active CNS metastases by CT scan or MRI



  • Over 18

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 4 months


  • WBC greater than 2,500/mm^3
  • Neutrophil count greater than 1,000/mm^3
  • Lymphocyte count greater than 700/mm^3
  • Platelet count greater than 75,000/mm^3
  • Hemoglobin greater than 9 g/dL
  • No bleeding disorders


  • Bilirubin less than 2.0 mg/dL
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative


  • Creatinine less than 2.5 mg/dL


  • No clinically significant heart disease


  • No clinically significant respiratory disease


  • No active systemic infection
  • No immunodeficiency disease

    • No evidence of HIV-1, HIV-2, or human T-cell lymphotropic virus-1
  • No active autoimmune disease including (but not limited to):

    • Lupus erythematosus
    • Autoimmune thyroiditis or uveitis
    • Multiple sclerosis
    • Inflammatory bowel disease


  • Stable medical condition
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 1 month after study participation
  • No organic brain syndrome or psychiatric illness that would preclude study compliance
  • No other concurrent active malignancy
  • No other concurrent serious illness that would preclude study treatment
  • No contraindication to leukapheresis


Biologic therapy

  • More than 4 weeks since prior immunotherapy
  • No other concurrent immunotherapy


  • More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas)
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent corticosteroids


  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to the spleen
  • Concurrent palliative radiotherapy allowed


  • Recovered from prior surgery
  • No prior splenectomy
  • No prior organ allograft
  • Concurrent surgery on selected metastases (e.g., because of pain or local complications such as compression) allowed


  • No other concurrent investigational drugs
  • No concurrent participation in another clinical trial

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 ClinicalTrials.gov identifier (NCT number): NCT00053391

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Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen
Erlangen, Germany, D-91052
Sponsors and Collaborators
University Hospital Erlangen
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Study Chair: Gerold Schuler Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PD Dr. med. univ. Beatrice Schuler-Thurner, Prinicipal Investigator Prof. Dr. Schuler Gerold, University Hospital Erlangen
ClinicalTrials.gov Identifier: NCT00053391    
Other Study ID Numbers: CDR0000258491
First Posted: January 28, 2003    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by PD Dr. med. univ. Beatrice Schuler-Thurner, University Hospital Erlangen:
stage III melanoma
stage IV melanoma
recurrent 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