myDC/pDC in Stage III Melanoma Patients

Radboud University Medical Center30 enrolled

Overview

This is an interventional study to test the immunogenicity of combined adjuvant myDC and pDC vaccination versus adjuvant myDC or pDC vaccination alone in stage III melanoma patients.

Stage lll melanoma patients will receive pDC (arm A, n=10), myDC (arm B, n=10) or combined pDC/myDC (arm C, n=10). Subsequent vaccinations will be performed according to the protocol: 2 biweekly vaccinations of intranodal injections with pDC, myDC or the combination with pDC and myDC. After each vaccination the investigators will examine peripheral blood for proliferative and humoral KLH immune responses. After the vaccinations, a DTH with peptide loaded blood DC is performed from which biopsies are taken for T cell analysis. lf patients remain disease free, the investigators will repeat this cycle with a 6 months interval up to a total of three cycles. lf a tumor recurrence occurs a biopsy will be taken for laboratory evaluation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Melanoma

Interventions

A: myDC vaccinationDRUG

B: pDC vaccinationDRUG

C: combined myDC/pDC vaccinationDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * stage III melanoma * WHO performance status 0-1 * radical lymph node dissection is schedule or performed within 12 weeks prior to start of study treatment Exclusion Criteria: * irresectable disease * any concurrent adjuvant therapy * concomitant use of oral immunosuppressive drugs * autoimmune diseases

Locations (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Outcomes

Primary Outcomes

immunogenicity - type I IFN

Type I IFN gene expression in PBMC shortly after vaccination. The occurrence of the type I IFN response in patients will be compared between the arms.

Time frame: up to 1.5 years

immunogenicity - response to KLH

Proliferative, effector cytokine and humoral responses to keyhole limpet hemocyanin (KLH).The occurrence of the response will be compared between the arms.

Time frame: up to 1.5 years

immunogenicity - T cells in DTH

Functional response and tetramer analysis of DTH infiltrating T cells against tumor peptides. The occurrence of the response will be compared between the arms.

Time frame: up to 1.5 years

Secondary Outcomes

biodistribution/localization of pDC and myDC in the lymph node

biodistribution/localization of the injected labeled pDC and/or myDC in the resected lymph node by multiple techniques

Time frame: within 1 week after vaccination 1

safety - Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0

Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0

Time frame: up to 1.5 years

quality of life

To assess the quality of life the EORTC QLQ-C30 questionnaire will be used.

Time frame: 5 years

progression-free survival

time from radical lymph node dissection to recurrence of (distant) disease

Time frame: 5 years

Data from ClinicalTrials.gov

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