Dendritic Cell Vaccination in Melanoma Patients Scheduled for Regional Lymph Node Dissection
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| ClinicalTrials.gov Identifier: NCT00243594 |
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Recruitment Status :
Completed
First Posted : October 24, 2005
Last Update Posted : February 19, 2009
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Melanoma Stage III or IV | Biological: Peptide-pulsed dendritic cells | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | September 1999 |
| Actual Primary Completion Date : | January 2009 |
- Biological: Peptide-pulsed dendritic cells
peptide-pulsed dendritic cells
- Immune response [ Time Frame: during the first 10 years ]
- Migration efficacy [ Time Frame: during the first 1-2 years ]
- Clinical response [ Time Frame: during the first 10 years ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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): NCT00243594
| Netherlands | |
| Radboud University Nijmegen Medical Centre | |
| Nijmegen, PO Box 9101, Netherlands, 6500 HB | |
| Principal Investigator: | Prof. C.J.A. Punt, MD, PhD | Radboud University Medical Center | |
| Principal Investigator: | Prof. C.G. Figdor, PhD | Radboud University Medical Center |
Publications:
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 |
| Other Study ID Numbers: |
2004-3126 2004-3126 KUN99-1950 |
| First Posted: | October 24, 2005 Key Record Dates |
| Last Update Posted: | February 19, 2009 |
| Last Verified: | February 2009 |
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Dendritic cells Immunotherapy Vaccination Melanoma |
Peptides MRI Scintigraphy Immune response |
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Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |