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Dendritic Cell Vaccination for Patients with Solid Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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:
  • - 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) 3.
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:

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01291420
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University Hospital, Antwerp
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Renal Cell Carcinoma, Sarcomas, Breast Cancers, Malignant Mesothelioma, Colorectal Tumors

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Edegem, Antwerp, Belgium

Status

Address

Antwerp University Hospital, Center for Cellular Therapy and Regenerative Medicine

Edegem, Antwerp, B-2650

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