EUCTR2011-000547-24-BEActive, not recruitingNot Applicable
Therapeutic efficacy of Wilms' tumor gene (WT1) mRNA-electroporated autologous dendritic cell vaccination in patients with solid tumors: a phase I/feasibility study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Antwerp University Hospital
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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:
- •a. Metastatic Breast Cancer or High Risk Locally Advanced Breast Cancer
- •i.Partial or Complete response after first line chemotherapy for both metastatic or locally advanced breast cancer. Minimal metastatic disease under hormonal treatment
- •ii.High risk Locally Advanced breast cancer defined as (and/or):
- •1. Age < 60 years
- •2. ER, PR and Her-2 Neu negative tumors
- •3. > 4 lymphnodes at initial presentation
- •4. Mastitis Carcinomatosis
- •5. Pregnancy associated Breast Cancer
- •b. Malignant Mesothelioma:
- •i.Partial or Complete response after first line chemotherapy not amendable for surgery
- •ii.Adjuvant after debulking surgery
- •c. Glioblastoma Multiforme
- •i.In Recurrent Disease after optimal treatment according to Stupp regimen
- •ii.In primary disease after debulking surgery, Temodal/radiotherapy and Temodal chemotherapy for 6 months
- •d. Sarcoma’s
- •i.After adjuvant chemotherapy for uterine sarcoma’s
- •ii.After Optimal or Debulking Surgery for liposarcoma’s, synovialcell sarcoma’s
- •iii. Recurrent sarcoma’s with limited disease
- •e. Colorectal tumors
- •i.K-ras wild-type tumors with inoperable lymphnode metastasis after standard chemotherapy (FOLFOX, FOLFIRI)
- •3. Patient Characteristics
- •a. Prior treatments: Patients must have received at least one prior chemotherapeutic regimen and must be more than 1 month past the last treatment.
- •b. Age: = 18 years
- •c. Performance status: WHO PS grade 0-1 (Appendix B)
- •d. Objectively assessable parameters of life expectancy: more than 3 months
- •e. Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV
- •f. No concomitant use of immunosuppressive drugs, hormonal treatment for breast cancer is allowed in case of stable disease
- •g. Adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal
- •h. 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
- •i. Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •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.
Investigators
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