Status:
COMPLETED
Platin-based Chemotherapeutics to Enhance Dendritic Cell Vaccine Efficacy in Melanoma Patients
Lead Sponsor:
Radboud University Medical Center
Conditions:
Melanoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is an exploratory study and the primary objective is the immunogenicity and feasibility of combined chemotherapy-DC vaccination. The secondary objectives are the toxicity and clinical efficacy. T...
Detailed Description
1. Rationale Investigators have explored immunotherapy and have now vaccinated well over 200 stage III and IV melanoma patients in the Netherlands with monocyte-derived dendritic cell (DC) vaccines an...
Eligibility Criteria
Inclusion
- All patients:
- histologically documented evidence of melanoma
- stage III or IV melanoma according to the 2001 AJCC criteria
- melanoma expressing gp100. Tyrosinase is not mandatory but will be assessed.
- 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 \>3x10\^9/l, lymphocytes \>0.8x10\^9/l, platelets \>100x10\^9/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: Stage III melanoma
- radical regional lymphnode dissection is 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
- any prior chemotherapy, immunotherapy or radiotherapy is allowed if completed more than 4 weeks prior to planned vaccination
- 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, known 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 symptomatic disease
- any serious clinical condition that may interfere with the safe administration of DC
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02285413
Start Date
February 1 2011
End Date
April 1 2016
Last Update
May 4 2016
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB