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Plasmacytoid Dendritic Cells in Vaccination of Stage IV Melanoma Patients: a Phase I Study

Phase 1
18 Years
75 Years
Open (Enrolling)

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Trial Information

Plasmacytoid Dendritic Cells in Vaccination of Stage IV Melanoma Patients: a Phase I Study

Inclusion Criteria:

- Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH < 2x
upper limit of normal

- Histological proof of cutaneous melanoma

- Melanoma expressing tyrosinase and/or gp100 (approximately 20% of cells or more
determined by immunohistochemistry staining)

- HLA Type A2

- WBC > 3.0 * 10E9/l, lymphocytes > 0.8 * 10E9/l, platelets > 100 * 10E9/l, serum
creatinine < 150 umol/l, serum bilirubin < 25 umol/l, normal liver function

- Expected adequacy of follow up

- Written informed consent

Exclusion Criteria:

- autoimmune disorders, concomitant use of immunosuppressive drugs

- serious concomitant disease, serious active infections, other malignancy in the past
5 years with the exception of curatively treated carcinoma in-situ of the
cervix/squamous cell carcinoma of the skin

- known allergy to shell fish (vaccine contains KLH)

- pregnancy or lactation

- clinical signs of CNS metastases, in patients with a clinical suspicion of CNS
metastases, a CT scan of the brain should be performed to exclude this

- prior chemotherapy, immunotherapy, or radiotherapy within three months before planned
vaccination is allowed

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

intervention-related toxicity

Outcome Description:

all adverse events within a time frame of 3 weeks after the last vaccination will be scored according to Common Terminology Criteria for Adverse Events (CTCAE)Version 4.0

Outcome Time Frame:

Within the first 6 months

Safety Issue:


Principal Investigator

C J A Punt, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University


Netherlands: Medical Ethics Review Committee (METC)

Study ID:




Start Date:

February 2008

Completion Date:

December 2013

Related Keywords:

  • Melanoma
  • Dendritic Cells
  • Melanoma