search
Back to results

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

Primary Purpose

Melanoma Stage III or IV

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Peptide-pulsed dendritic cells
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma Stage III or IV focused on measuring Dendritic cells, Immunotherapy, Vaccination, Melanoma, Peptides, MRI, Scintigraphy, Immune response

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud University Nijmegen Medical Centre

Outcomes

Primary Outcome Measures

Immune response
Migration efficacy

Secondary Outcome Measures

Clinical response

Full Information

First Posted
October 21, 2005
Last Updated
February 18, 2009
Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society
search

1. Study Identification

Unique Protocol Identification Number
NCT00243594
Brief Title
Dendritic Cell Vaccination in Melanoma Patients Scheduled for Regional Lymph Node Dissection
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma Stage III or IV
Keywords
Dendritic cells, Immunotherapy, Vaccination, Melanoma, Peptides, MRI, Scintigraphy, Immune response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Peptide-pulsed dendritic cells
Intervention Description
peptide-pulsed dendritic cells
Primary Outcome Measure Information:
Title
Immune response
Time Frame
during the first 10 years
Title
Migration efficacy
Time Frame
during the first 1-2 years
Secondary Outcome Measure Information:
Title
Clinical response
Time Frame
during the first 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. C.J.A. Punt, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. C.G. Figdor, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
PO Box 9101
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
16110035
Citation
de Vries IJ, Bernsen MR, Lesterhuis WJ, Scharenborg NM, Strijk SP, Gerritsen MJ, Ruiter DJ, Figdor CG, Punt CJ, Adema GJ. Immunomonitoring tumor-specific T cells in delayed-type hypersensitivity skin biopsies after dendritic cell vaccination correlates with clinical outcome. J Clin Oncol. 2005 Aug 20;23(24):5779-87. doi: 10.1200/JCO.2005.06.478.
Results Reference
background
PubMed Identifier
15477299
Citation
Lesterhuis WJ, de Vries IJ, Adema GJ, Punt CJ. Dendritic cell-based vaccines in cancer immunotherapy: an update on clinical and immunological results. Ann Oncol. 2004;15 Suppl 4:iv145-51. doi: 10.1093/annonc/mdh919. No abstract available.
Results Reference
background
PubMed Identifier
15122249
Citation
Figdor CG, de Vries IJ, Lesterhuis WJ, Melief CJ. Dendritic cell immunotherapy: mapping the way. Nat Med. 2004 May;10(5):475-80. doi: 10.1038/nm1039.
Results Reference
background
PubMed Identifier
14613986
Citation
de Vries IJ, Lesterhuis WJ, Scharenborg NM, Engelen LP, Ruiter DJ, Gerritsen MJ, Croockewit S, Britten CM, Torensma R, Adema GJ, Figdor CG, Punt CJ. Maturation of dendritic cells is a prerequisite for inducing immune responses in advanced melanoma patients. Clin Cancer Res. 2003 Nov 1;9(14):5091-100.
Results Reference
background
PubMed Identifier
12517769
Citation
De Vries IJ, Krooshoop DJ, Scharenborg NM, Lesterhuis WJ, Diepstra JH, Van Muijen GN, Strijk SP, Ruers TJ, Boerman OC, Oyen WJ, Adema GJ, Punt CJ, Figdor CG. Effective migration of antigen-pulsed dendritic cells to lymph nodes in melanoma patients is determined by their maturation state. Cancer Res. 2003 Jan 1;63(1):12-7.
Results Reference
background
PubMed Identifier
12218781
Citation
de Vries IJ, Eggert AA, Scharenborg NM, Vissers JL, Lesterhuis WJ, Boerman OC, Punt CJ, Adema GJ, Figdor CG. Phenotypical and functional characterization of clinical grade dendritic cells. J Immunother. 2002 Sep-Oct;25(5):429-38. doi: 10.1097/00002371-200209000-00007.
Results Reference
background
PubMed Identifier
15766677
Citation
Adema GJ, de Vries IJ, Punt CJ, Figdor CG. Migration of dendritic cell based cancer vaccines: in vivo veritas? Curr Opin Immunol. 2005 Apr;17(2):170-4. doi: 10.1016/j.coi.2005.01.004.
Results Reference
background
PubMed Identifier
16258544
Citation
de Vries IJ, Lesterhuis WJ, Barentsz JO, Verdijk P, van Krieken JH, Boerman OC, Oyen WJ, Bonenkamp JJ, Boezeman JB, Adema GJ, Bulte JW, Scheenen TW, Punt CJ, Heerschap A, Figdor CG. Magnetic resonance tracking of dendritic cells in melanoma patients for monitoring of cellular therapy. Nat Biotechnol. 2005 Nov;23(11):1407-13. doi: 10.1038/nbt1154. Epub 2005 Oct 30.
Results Reference
background
PubMed Identifier
23382117
Citation
Aarntzen EH, Srinivas M, Bonetto F, Cruz LJ, Verdijk P, Schreibelt G, van de Rakt M, Lesterhuis WJ, van Riel M, Punt CJ, Adema GJ, Heerschap A, Figdor CG, Oyen WJ, de Vries IJ. Targeting of 111In-labeled dendritic cell human vaccines improved by reducing number of cells. Clin Cancer Res. 2013 Mar 15;19(6):1525-33. doi: 10.1158/1078-0432.CCR-12-1879. Epub 2013 Feb 4.
Results Reference
derived
Links:
URL
http://www.umcn.nl
Description
Home page of the Radboud University Nijmegen Medical Centre

Learn more about this trial

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

We'll reach out to this number within 24 hrs