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Vaccine Therapy in Treating Patients With Unresected 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.
ClinicalTrials.gov Identifier: NCT00107159
Recruitment Status : Completed
First Posted : April 6, 2005
Last Update Posted : November 6, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines made from a person's white blood cells and a donor's tumor cells may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with unresected stage III or stage IV melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine Phase 2

Detailed Description:



  • Determine the clinical activity of vaccine therapy comprising autologous dendritic cells pulsed with allogeneic melanoma tumor cell lysates (IDD-3), as measured by tumor control, in patients with unresected stage IIIB or IIIC or stage IV melanoma.


  • Determine the immunologic activity of this vaccine, as measured by T-cell and antibody responses to lysate or to melanoma antigens or peptides, in these patients.
  • Determine the safety of this vaccine, as measured by the incidence and severity of adverse events, in these patients.

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

Patients undergo apheresis to collect peripheral blood mononuclear cells (PBMCs). The PBMCs are cultured with sargramostim (GM-CSF) and interleukin-13 for the production of dendritic cells. The dendritic cells are then pulsed with lysates from 3 allogeneic melanoma tumor cell lines (IDD-3) to produce the vaccine.

Patients receive vaccine therapy comprising IDD-3 administered as 1 subcutaneous and 5 intradermal injections at each of the 2 uninvolved lymph node-bearing regions once in weeks 0, 2, 4, 6, 8, 10, 16, and 22 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 2, 10, 18, and 26 weeks.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Matured Dendritic Cells Pulsed Ex Vivo With 3 Melanoma Cell Line Lysates (IDD-3) in Patients With In-Transit or Metastatic Melanoma
Study Start Date : January 2005
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks

Secondary Outcome Measures :
  1. Safety
  2. Immune response

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 primary cutaneous or unknown primary melanoma, including 1 of the following stages:

    • Stage IIIB or IIIC disease

      • Unresected, in-transit lymph node metastases (N2c or N3)
    • Stage IV disease

      • Distant skin, subcutaneous, lymph node, or pulmonary metastases (M1a or M1b)

        • No cerebral, bone, or other visceral metastases
  • At least 1 measurable or evaluable lesion

    • Small-volume multiple cutaneous deposits allowed
  • Progressive disease, as defined by 1 of the following criteria:

    • At least 20% increase in size in ≥ 1 measurable or evaluable lesion
    • Appearance of ≥ 1 new lesion since or during last treatment (if applicable) AND within the past 3 months



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months


  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL (transfusion allowed)


  • SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Lactic dehydrogenase normal
  • No active hepatitis B or C infection


  • Creatinine ≤ 1.5 times ULN


  • No history of autoimmune disease

    • Vitiligo allowed
  • No history of immunodeficiency syndrome
  • No active bacterial, viral, or fungal infection within the past 72 hours
  • HIV-1 or -2 negative
  • Human T-cell lymphotrophic virus-I or -II negative


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No contraindication to apheresis
  • No other significant medical or surgical condition that would preclude study participation


Biologic therapy

  • No prior vaccine therapy with ≥ 1 melanoma antigen or peptide
  • More than 4 weeks since prior biologic therapy


  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

  • No concurrent chronic systemic corticosteroids


  • More than 4 weeks since prior radiotherapy


  • Not specified


  • More than 4 weeks since prior investigational products
  • More than 4 weeks since prior chronic systemic immunosuppressive treatment
  • No concurrent medication or treatment regimen that would prelude study participation
  • No other concurrent anticancer treatment
  • No other concurrent immunosuppressive treatment

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): NCT00107159

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United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
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Study Chair: Antoni Ribas, MD Jonsson Comprehensive Cancer Center
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00107159    
Other Study ID Numbers: CDR0000422429
First Posted: April 6, 2005    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: April 2007
Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage III melanoma
stage IV 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