Natural Dendritic Cell Vaccines in Metastatic Melanoma Patients

Radboud University Medical Center

Status and phase: Completed; Phase 1

Conditions: Melanoma

Treatments: Biological: PDC or myDC

Study type: Interventional

Funder types: Other

Identifiers

NCT01690377

KWF 2004-3127

2004-093

Details and patient eligibility

About

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. Several subsets of dendritic cells have been characterized in the peripheral blood. One such subset is referred to as plasmacytoid dendritic cells (PDC), another as myeloid dendritic cells (myDC). To date PDC and myDC have not been evaluated for their capability to induce anti-tumor immune responses in patients. For this reason the investigators will perform a safety and efficacy study with PDC and myDC in stage IV melanoma patients.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

1

Experimental group

Description:

PDC or myDC

Treatment:

Biological: PDC or myDC