Natural Dendritic Cell Vaccines in Metastatic Melanoma Patients

NCT01690377 | Completed Phase 1

• 2 other identifiers: 2004-093KWF 2004-3127
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma

Keywords

Dendritic Cells

Outcome Measures

Primary Outcomes (1)

• intervention-related toxicity

  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

  Within the first 6 months

Secondary Outcomes (1)

• Immunological response

  Within the first year

Study Arms (1)

1

EXPERIMENTAL

PDC or myDC

Biological: PDC or myDC

Interventions

PDC or myDC BIOLOGICAL

PDC or myDC; first patient 0.3 \* 10E6 PDC; second and third 1 \* 10E6 PDC; fourth and fifth 3 \* 10E6 PDC.

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Melanoma

Interventions

phosducin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• C J A Punt, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• C G Figdor, PhD

  Radboud University Nijmegen Medical Centre / Nijmegen Centre for Molecular Life Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: September 21, 2012
• Study Start: February 1, 2008
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 8, 2016

Record last verified: 2014-11

Locations

NL (1)