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Therapeutic Efficacy of Wilms' Tumor Gene (WT1) mRNA-electroporated Autologous Dendritic Cell Vaccination in Patients With Solid Tumors: a Phase I/Feasibility Study

Phase 1/Phase 2
18 Years
Open (Enrolling by invite only)
Glioblastoma, Renal Cell Carcinoma, Sarcomas, Breast Cancers, Malignant Mesothelioma, Colorectal Tumors

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Trial Information

Therapeutic Efficacy of Wilms' Tumor Gene (WT1) mRNA-electroporated Autologous Dendritic Cell Vaccination in Patients With Solid Tumors: a Phase I/Feasibility Study

Inclusion Criteria:

1. 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)

2. 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

- Recurrent sarcoma's with limited disease

- Colorectal tumors

- K-ras wild-type tumors with inoperable lymphnode metastasis after standard
chemotherapy (FOLFOX, FOLFIRI)

3. 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

- Women of child-bearing potential should use adequate contraception prior to
study entry and for the duration of study participation

Exclusion Criteria:

1. Subjects with concurrent additional malignancy (with exception of non-melanoma skin
cancers and carcinoma in situ of the cervix)

2. Subjects who are pregnant

3. Subjects who have sensitivity to drugs that provide local anesthesia

4. Subjects needing corticosteroids 1 mg/kg during vaccination; corticosteroids are
allowed as part of their treatment when taken ≥ 30 days before the start of

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Immunogenicity of intradermal DC vaccination

Outcome Description:

Immunogenicity of intradermal DC vaccination (cellular + humoral immunity against WT1 antigen) as measured by: In vivo cytokine response (serum concentration of cytokines) In vivo anti-WT1 antibody responses 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 Delayed type hypersensitivity (DTH) responses Quantitative and qualitative FACS analysis of WT1-specific-positive CD8+ T cells using HLA-A2 WT1 multimers

Outcome Time Frame:

week 8 and in follow-up per 2 months

Safety Issue:



Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

CCRG 11-001



Start Date:

February 2011

Completion Date:

Related Keywords:

  • Glioblastoma
  • Renal Cell Carcinoma
  • Sarcomas
  • Breast Cancers
  • Malignant Mesothelioma
  • Colorectal Tumors
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Colorectal Neoplasms
  • Glioblastoma
  • Mesothelioma
  • Sarcoma