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Natural Dendritic Cell Vaccines in Metastatic Melanoma Patients

Primary Purpose

Melanoma

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

PDC or myDC

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Dendritic Cells

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Radboud University Nijmegen Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

PDC or myDC

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Immunological response

The immunological response will be determined by tetramer sampling of skin-test derived lymphocyte cultures and peripheral blood after vaccination

Full Information

NCT ID

NCT01690377

First Posted

February 5, 2008

Last Updated

December 7, 2016

Sponsor

Radboud University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01690377

Brief Title

Natural Dendritic Cell Vaccines in Metastatic Melanoma Patients

Official Title

Plasmacytoid Dendritic Cells in Vaccination of Stage IV Melanoma Patients: a Phase I Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radboud University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

Dendritic Cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

PDC or myDC

Intervention Type

Biological

Intervention Name(s)

PDC or myDC

Intervention Description

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

Primary Outcome Measure Information:

Title

intervention-related toxicity

Description

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

Time Frame

Within the first 6 months

Secondary Outcome Measure Information:

Title

Immunological response

Description

The immunological response will be determined by tetramer sampling of skin-test derived lymphocyte cultures and peripheral blood after vaccination

Time Frame

Within the first year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

C J A Punt, MD, PhD

Organizational Affiliation

Radboud University Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

C G Figdor, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Radboud University Nijmegen Medical Centre

City

Nijmegen

ZIP/Postal Code

6500 HB

Country

Netherlands

12. IPD Sharing Statement

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Natural Dendritic Cell Vaccines in Metastatic Melanoma Patients

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