myDC/pDC in Stage III Melanoma Patients

Melanoma Clinical Trial

Official title:

Myeloid and Plasmacytoid Blood Dendritic Cells for Immunotherapy of Stage III Melanoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574377
• Other study ID #: NL49528.000.14
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2015
• Est. completion date: September 2021

Study information

• Verified date: September 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• A: myDC vaccination

• B: pDC vaccination

• C: combined myDC/pDC vaccination

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 1.5 years
Primary	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.	up to 1.5 years
Primary	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.	up to 1.5 years
Secondary	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	within 1 week after vaccination 1
Secondary	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	up to 1.5 years
Secondary	quality of life	To assess the quality of life the EORTC QLQ-C30 questionnaire will be used.	5 years
Secondary	progression-free survival	time from radical lymph node dissection to recurrence of (distant) disease	5 years
Secondary	overall survival	time from radical lymph node dissection to death	5 years