Toll-like Receptor (TLR) Ligand Matured Dendritic Cell Vaccination in Melanoma Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Radboud University
Information provided by (Responsible Party):
Kees Punt, Radboud University
ClinicalTrials.gov Identifier:
NCT00940004
First received: June 25, 2009
Last updated: February 7, 2012
Last verified: February 2012
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Purpose
Objectives:
This is an exploratory study, consisting of two parts. In part I a dose escalation is performed and the primary objective is the safety of different doses of TLR-dendritic cell (TLR-DC). In part II TLR-DC vaccination will be compared with cytokine-matured DC vaccination and the primary objective of this part is the immunological response to TLR-DC vaccination, with toxicity and clinical efficacy being secondary objectives. These studies will provide important data on the safety and immunological effects of TLR-matured DC.
Study design:
This study is an open label prospective exploratory intervention study.
Study population:
The investigators' study population consists of HLA-A2.1 positive melanoma patients, with proven expression of melanoma associated tumor antigens gp100 and tyrosinase. Melanoma patients with regional lymph node metastasis in whom a radical lymph node dissection is planned or performed within 2 months of inclusion in this study (further referred to as stage III) and melanoma patients with measurable distant metastases (further referred to as stage IV) will be included.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Biological: autologous dendritic cell vaccination |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | TLR Ligand Matured Dendritic Cell Vaccination in Melanoma Patients: the Key Towards a More Potent Immune Induction? |
Resource links provided by NLM:
Further study details as provided by Radboud University:
Primary Outcome Measures:
- Toxicity of TLR-matured DC (part I) and immunological response upon vaccination with TLR-matured DC (part II) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- vaccination related toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]in terms of local injection site reaction, flu-like symptoms, or otherwise related to vaccination, scored according to CTC version 3.0
- clinical efficacy (progression free survival) [ Time Frame: 5 years ] [ Designated as safety issue: No ]time to progression from date of start (apheresis) will be recorded
| Estimated Enrollment: | 45 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: cytokine matured DC
autologous dendritic cells matured with standard cytokine cocktail and electroporated with mRNA encoding tumor associated antigens
|
Biological: autologous dendritic cell vaccination
Autologous monocyte-derived dendritic cells electroporated with mRNA encoding gp100 and tyrosinase and matured with either cytokines or TLR ligands. Dendritic cells are vaccinated intradermal/intravenously 3 times with biweekly intervals every 6 months, if no signs of progression, for a total of 9 vaccinations.
|
|
Experimental: TLR ligand matured DC
autologous TLR-ligand matured dendritic cells electroporated with mRNA encoding tumor associated antigens
|
Biological: autologous dendritic cell vaccination
Autologous monocyte-derived dendritic cells electroporated with mRNA encoding gp100 and tyrosinase and matured with either cytokines or TLR ligands. Dendritic cells are vaccinated intradermal/intravenously 3 times with biweekly intervals every 6 months, if no signs of progression, for a total of 9 vaccinations.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
All patients:
- histologically documented evidence of melanoma
- stage III or IV melanoma according to the 2001 AJCC criteria
- HLA-A2.1 phenotype melanoma expressing gp100 (compulsory) and tyrosinase (non- compulsory)
- WHO performance status 0-1 (Karnofsky 100-70)
- life expectancy > 3 months
- age 18-70 years
- no clinical signs or symptoms of CNS metastases
- WBC > 3.0x109/l, lymphocytes > 0.8x109/l, platelets > 100x109/l, serum creatinine < 150 µmol/l, serum bilirubin < 25 µmol/l
- normal serum LDH (< 450 U/l)
- expected adequacy of follow-up
- no pregnant or lactating women
- written informed consent
And in addition for Part I + II:
- stage III melanoma: radical regional lymphnode dissection is planned or performed
- stage IV melanoma: at least one unidimensional measurable target lesions according to RECIST, not previously irradiated, and no significant symptoms of disease requiring other palliative treatments
Exclusion Criteria:
- prior chemotherapy, immunotherapy or radiotherapy < 4 weeks prior to planned vaccination or presence of treatment-related toxicity
- history of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix serious active infections, HbsAg or HIV positive or autoimmune diseases or organ allografts
- concomitant use of immunosuppressive drugs
- known allergy to shell fish (since it contains KLH)
- rapidly progressive disease
- any serious clinical condition that may interfere with the safe administration of DC
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940004
Locations
| Netherlands | |
| Radboud University Nijmegen Medical Centre | |
| Nijmegen, Gelderland, Netherlands, 6500HB | |
Sponsors and Collaborators
Radboud University
Investigators
| Principal Investigator: | C.J.A. Punt, prof.dr. | Radboud University Nijmegen Medical Centre, dept of Medical Oncology |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kees Punt, professor, Radboud University |
| ClinicalTrials.gov Identifier: | NCT00940004 History of Changes |
| Other Study ID Numbers: | NL22750.000.08, KUN2006-3699 |
| Study First Received: | June 25, 2009 |
| Last Updated: | February 7, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
dendritic cell vaccination melanoma toll like receptor ligands vaccines |
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 May 22, 2013