Dendritic Cell Vaccination in Melanoma Patients Scheduled for Regional Lymph Node Dissection

This study has been completed.
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00243594
First received: October 21, 2005
Last updated: February 18, 2009
Last verified: February 2009
  Purpose

Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As such they are currently used in clinical vaccination protocols in cancer patients, and both immunological and clinical responses have been observed. For these therapies accurate delivery to target organs is essential. Correct delivery and subsequent migration of vaccinated DCs to regional lymph nodes is of paramount importance for effective stimulation of the immune system. Currently it is not known what the best route of administration is for DC vaccines.

Using magnetically labeled DCs, we investigate the potential of MRI cell tracking to monitor DC therapy. This is investigated in stage III/IV melanoma patients in whom a regional lymph node dissection is scheduled. Autologous monocyte-derived DCs are labeled with the clinically approved superparamagnetic iron oxide (SPIO) formulation Endorem and 111In-oxine and injected either in the skin or directly in lymph nodes under ultrasound guidance. Two days after vaccination patients are monitored with scintigraphy and MR imaging. Lymph nodes are then resected. Subsequently patients receive 3 more vaccination with DCs. During and after therapy immune responses against the used melanoma peptides are monitored.


Condition Intervention Phase
Melanoma Stage III or IV
Biological: Peptide-pulsed dendritic cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Active Immunization of Patients With Stage III and IV Melanoma in Whom a Regional Lymph Node Dissection is Planned, With Peptide-Pulsed Dendritic Cells: Evaluation of in Vivo Immune and Clinical Response and Migration

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Immune response [ Time Frame: during the first 10 years ] [ Designated as safety issue: No ]
  • Migration efficacy [ Time Frame: during the first 1-2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response [ Time Frame: during the first 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 1999
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Peptide-pulsed dendritic cells
    peptide-pulsed dendritic cells
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Histologically documented evidence of melanoma

Stage III-IV melanoma according to the 2001 AJCC criteria

Radical lymph node dissection planned, either with curative (stage III) or palliative (stage IV) intent

Melanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory)

HLA-A2.1 phenotype according to lymphocyte HLA typing

ECOG performance status 0-1, life expectancy > 3 months

Age 18-75 years

Interval since last prior chemotherapy, immunotherapy or radiotherapy at least 4 weeks, no residual toxicity of prior treatment.

WBC > 3.0 x 109/l, lymphocytes > 0.8 x 109/l, platelets > 100 x 109/l, serum creatinine < 150 μmol/l, serum bilirubin < 25 μmol/l

Written informed consent

Expected adequacy of follow-up

Exclusion criteria:

No clinical signs of CNS metastases, in patients with a clinical suspicion of other metastases diagnostic tests should be performed to exclude this.

No concomitant use of corticosteroids or other immunosuppressive agents

No history of second malignancy within the last 5 years. Adequately treated basal carcinoma of skin or carcinoma in situ of cervix is acceptable within this period

No serious concomitant disease, no active infections. No autoimmune disease or organ allografts, no clinical suspicion of HIV or Hepatitis B

No contra-indications for MRI-scanning: claustrophobia, pacemaker or pacemaker threads, cerebral clips or artificial heartvalves, internal hearing prosthesis No known allergy to shell fish (contains KLH)

No pregnant or lactating women

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00243594

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, PO Box 9101, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Dutch Cancer Society
Investigators
Principal Investigator: Prof. C.J.A. Punt, MD, PhD Radboud University
Principal Investigator: Prof. C.G. Figdor, PhD Radboud University
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: C.J.A. Punt, MD, PhD, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00243594     History of Changes
Other Study ID Numbers: 2004-3126, 2004-3126, KUN99-1950
Study First Received: October 21, 2005
Last Updated: February 18, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Dendritic cells
Immunotherapy
Vaccination
Melanoma
Peptides
MRI
Scintigraphy
Immune response

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 18, 2014