Dendritic Cell Vaccination for Patients with Solid Tumors

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 sensitivity to 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.