Status:
COMPLETED
Toll-like Receptor (TLR) Ligand Matured Dendritic Cell Vaccination in Melanoma Patients
Lead Sponsor:
Radboud University Medical Center
Conditions:
Melanoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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). ...
Detailed Description
1. Rationale Immunotherapy applying ex vivo generated and tumor-antigen-loaded dendritic cells (DC) has now successfully been introduced in the clinic. A limited, but consistent, number of objecti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00940004
Start Date
June 1 2009
End Date
November 1 2014
Last Update
April 17 2017
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500HB