Dendritic Cell Vaccination for Patients with Solid Tumors

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