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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. 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)

Tracking Information
First Submitted Date  ICMJE April 5, 2005
First Posted Date  ICMJE April 6, 2005
Last Update Posted Date November 6, 2013
Study Start Date  ICMJE January 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2007)
Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2007)
  • Safety
  • Immune response
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV Melanoma
Official Title  ICMJE 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
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma (Skin)
Intervention  ICMJE Biological: autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine
Study Arms  ICMJE Not Provided
Publications * Ribas A, Camacho LH, Lee SM, Hersh EM, Brown CK, Richards JM, Rodriguez MJ, Prieto VG, Glaspy JA, Oseguera DK, Hernandez J, Villanueva A, Chmielowski B, Mitsky P, Bercovici N, Wasserman E, Landais D, Ross MI. Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma. J Transl Med. 2010 Sep 27;8:89. doi: 10.1186/1479-5876-8-89.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2010
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE


  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00107159
Other Study ID Numbers  ICMJE CDR0000422429
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Antoni Ribas, MD Jonsson Comprehensive Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date April 2007

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