Dendritic cell vaccine to treat cancer patients

• Conditions: Therapeutic vaccination with dendritic cells loaded with Wilms' tumor 1 protein in patients with solid tumors; MedDRA version: 14.0Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10046859Term: VaccinationSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2011-000547-24-BE
• Lead Sponsor: Antwerp University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-23
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified