Dendritic Cell Vaccination for Patients with Solid Tumors

Antwerp University Hospital (UZA)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Glioblastoma

Malignant Mesothelioma

Colorectal Tumors

Breast Cancers

Renal Cell Carcinoma

Sarcomas

Treatments

Biological: autologous dendritic cell vaccination

Study type

Interventional

Funder types

Other

Identifiers

NCT01291420

CCRG 11-001

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.