Dendritic Cell Vaccination for Patients With Solid Tumors
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ClinicalTrials.gov Identifier: NCT01291420
Recruitment Status : Unknown
Verified July 2013 by University Hospital, Antwerp. Recruitment status was: Enrolling by invitation
The aim of this study is to evaluate the immunogenicity and clinical efficacy of intradermal vaccination with autologous RNA-modified dendritic cells (DCs) - engineered to express the WT1 protein - in patients with limited spread metastatic solid tumors, i.e. breast cancers, glioblastoma grade IV, sarcomas, malignant mesothelioma and colorectal tumors. Based on the results of our previously performed phase I study with autologous WT1 mRNA-transfected DC, the investigators hypothesize that the vaccination with DC will be well-tolerated and will result in an increase in WT1-specific CD8+ T cell responses.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Pregnancy associated Breast Cancer
Partial or Complete response after first line chemotherapy not amendable for surgery
Adjuvant after debulking surgery
In Recurrent Disease after optimal treatment according to Stupp regimen
In primary disease after debulking surgery, Temodal/radiotherapy and Temodal chemotherapy for 6 months
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
K-ras wild-type tumors with inoperable lymphnode metastasis after standard chemotherapy (FOLFOX, FOLFIRI)
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
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.