Dendritic Cell Vaccination in Melanoma Patients Scheduled for Regional Lymph Node Dissection
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| First Received Date ICMJE | October 21, 2005 | ||||||||
| Last Updated Date | February 18, 2009 | ||||||||
| Start Date ICMJE | September 1999 | ||||||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00243594 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Clinical response [ Time Frame: during the first 10 years ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Clinical response | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Dendritic Cell Vaccination in Melanoma Patients Scheduled for Regional Lymph Node Dissection | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Melanoma Stage III or IV | ||||||||
| Intervention ICMJE | Biological: Peptide-pulsed dendritic cells
peptide-pulsed dendritic cells |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00243594 | ||||||||
| Other Study ID Numbers ICMJE | 2004-3126, 2004-3126, KUN99-1950 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | C.J.A. Punt, MD, PhD, Radboud University Nijmegen Medical Centre | ||||||||
| Study Sponsor ICMJE | Radboud University | ||||||||
| Collaborators ICMJE | Dutch Cancer Society | ||||||||
| Investigators ICMJE |
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| Information Provided By | Radboud University | ||||||||
| Verification Date | February 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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