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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
First Posted : February 8, 2011
Last Update Posted : July 12, 2013
Sponsor:
Information provided by:
University Hospital, Antwerp

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Renal Cell Carcinoma Sarcomas Breast Cancers Malignant Mesothelioma Colorectal Tumors Biological: autologous dendritic cell vaccination Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Efficacy of Wilms' Tumor Gene (WT1) mRNA-electroporated Autologous Dendritic Cell Vaccination in Patients With Solid Tumors: a Phase I/Feasibility Study
Study Start Date : February 2011
Estimated Primary Completion Date : February 2014



Intervention Details:
  • Biological: autologous dendritic cell vaccination
    4 biweekly intradermal DC injections of 10*10E6 DCs (500 µL) at 5 sites (100 µL/site) in the ventromedial regions of the upper arm approximately 5-10 cm of the regional lymph nodes


Primary Outcome Measures :
  1. Immunogenicity of intradermal DC vaccination [ Time Frame: up to 2 months ]

    Immunogenicity of intradermal DC vaccination (cellular + humoral immunity against WT1 antigen) as measured by:

    1. In vivo cytokine response (serum concentration of cytokines)
    2. In vivo anti-WT1 antibody responses
    3. In vitro T cell reactivity towards MHC class I and II-restricted WT1 epitopes by multiplex-cytokine assay using peripheral blood and DTH-infiltrating T cells
    4. Delayed type hypersensitivity (DTH) responses
    5. Quantitative and qualitative FACS analysis of WT1-specific-positive CD8+ T cells using HLA-A2 WT1 multimers



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291420


Locations
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Belgium
Antwerp University Hospital, Center for Cellular Therapy and Regenerative Medicine
Edegem, Antwerp, Belgium, B-2650
Sponsors and Collaborators
University Hospital, Antwerp

Publications:
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Responsible Party: Prof. dr. Zwi N. Berneman, Antwerp University Hospital, Hematology
ClinicalTrials.gov Identifier: NCT01291420     History of Changes
Other Study ID Numbers: CCRG 11-001
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: July 12, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Glioblastoma
Carcinoma, Renal Cell
Mesothelioma
Colorectal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Adenoma
Neoplasms, Mesothelial
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases