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Natural Dendritic Cell Vaccines in Metastatic Melanoma Patients

NCT ID: NCT01690377

Last Updated: 2016-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma

Keywords

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Dendritic Cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

PDC or myDC

Group Type EXPERIMENTAL

PDC or myDC

Intervention Type BIOLOGICAL

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

Interventions

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PDC or myDC

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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C J A Punt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

C G Figdor, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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KWF 2004-3127

Identifier Type: -

Identifier Source: secondary_id

2004-093

Identifier Type: -

Identifier Source: org_study_id