From the blog

Dendritic Cell Vaccination for Patients With Solid Tumors

Published: November 5, 2014


Primary Outcome Measure:

  • Immunogenicity of intradermal DC vaccination [ Time Frame: up to 2 months ] [ Designated as safety issue: Yes ]

    Immunogenicity of intradermal DC vaccination (cellular + humoral immunity against WT1 antigen) as measured by:

    1. In vivo cytokine response (serum concentration of cytokines)
    2. In vivo anti-WT1 antibody responses
    3. In vitro T cell reactivity towards MHC class I and II-restricted WT1 epitopes by multiplex-cytokine assay using peripheral blood and DTH-infiltrating T cells
    4. Delayed type hypersensitivity (DTH) responses
    5. Quantitative and qualitative FACS analysis of WT1-specific-positive CD8+ T cells using HLA-A2 WT1 multimers

Eligibility Criteria

Inclusion Criteria:
  • Tumor type: Metastatic or Locally Advanced Breast Cancer; Malignant Mesothelioma; Glioblastoma Multiforme (Grade IV); Sarcoma’s; Colorectal tumors or rare tumors (less than 500 patients a year)
  • Extent of disease:
    • Metastatic Breast Cancer or High Risk Locally Advanced Breast Cancer
      • Partial or Complete response after first line chemotherapy for both metastatic or locally advanced breast cancer. Minimal metastatic disease under hormonal treatment
      • High risk Locally Advanced breast cancer defined as (and/or):
        • Age < 60 years old
        • ER, PR and Her-2 Neu negative tumors
        • > 4 lymphnodes at initial presentation
        • Mastitis Carcinomatosis
        • Pregnancy associated Breast Cancer
    • Malignant Mesothelioma:
      • Partial or Complete response after first line chemotherapy not amendable for surgery
      • Adjuvant after debulking surgery
    • Glioblastoma Multiforme
      • In Recurrent Disease after optimal treatment according to Stupp regimen
      • In primary disease after debulking surgery, Temodal/radiotherapy and Temodal chemotherapy for 6 months
    • Sarcoma’s
      • After adjuvant chemotherapy for uterine sarcoma’s
      • After Optimal or Debulking Surgery for liposarcoma’s, synovial cell sarcoma’s
      • Recurrent sarcoma’s with limited disease
    • Colorectal tumors
      • K-ras wild-type tumors with inoperable lymphnode metastasis after standard chemotherapy (FOLFOX, FOLFIRI)
  • Patient Characteristics
    • Prior treatments: Patients must have received at least one prior chemotherapeutic regimen and must be more than 1 month past the last treatment.
    • Age: ≥ 18 years old
    • Performance status: WHO PS grade 0-1 (Appendix B)
    • Objectively assessable parameters of life expectancy: more than 3 months
    • Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV
    • No concomitant use of immunosuppressive drugs, hormonal treatment for breast cancer is allowed in case of stable disease
    • Adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal
    • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    • Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation
Exclusion Criteria:
  • Subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix)
  • Subjects who are pregnant
  • Subjects who have a sensitivity o drugs that provide local anesthesia
  • Subjects needing corticosteroids 1 mg/kg during vaccination; corticosteroids are allowed as part of their treatment when taken ≥ 30 days before the start of vaccination
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