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
sarcoma's
- 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
trial
- 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
vaccination.