NCT02285413

Brief Summary

This is an exploratory study and the primary objective is the immunogenicity and feasibility of combined chemotherapy-DC vaccination. The secondary objectives are the toxicity and clinical efficacy. This study will provide important data on the immunological efficacy of DC immunochemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2013

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

4.7 years

First QC Date

May 11, 2013

Last Update Submit

May 3, 2016

Conditions

Melanoma

Keywords

MelanomaDendritic cellsCisplatinVaccineImmunotherapy

Outcome Measures

Primary Outcomes (2)

  • Immunogenicity: number of participants with KLH and/or tumor-specific antigens immune responses.

    5 years

  • Feasibility: % of vaccines meeting the release criteria.

    5 years

Secondary Outcomes (4)

  • Toxicity: number of Participants with Adverse Events.

    5 years

  • Progression-free survival

    5 years

  • Overall survival

    5 years

  • Best objective response (only in stage IV)

    5 years

Study Arms (2)

DC vaccination

EXPERIMENTAL

mature DC injected intradermally and intravenously loaded with mRNA encoding tumor-associated antigens gp100 and tyrosinase

Biological: DC vaccination

DC vaccination with cisplatinum

EXPERIMENTAL

mature DC injected intradermally and intravenously loaded with mRNA encoding tumor-associated antigens gp100 and tyrosinase. each DC vaccine will be preceded by cisplatin infusion: 50 mg/m2, 1-2h before DC injection.

Biological: DC vaccination with cisplatinum

Interventions

DC vaccinationBIOLOGICAL

DC vaccination without cisplatinum

DC vaccination
DC vaccination with cisplatinumBIOLOGICAL

DC vaccination with cisplatinum

DC vaccination with cisplatinum

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients:
  • histologically documented evidence of melanoma
  • stage III or IV melanoma according to the 2001 AJCC criteria
  • melanoma expressing gp100. Tyrosinase is not mandatory but will be assessed.
  • WHO performance status 0-1 (Karnofsky 100-70)
  • life expectancy ≥3 months
  • age 18-70 years
  • no clinical signs or symptoms of CNS metastases
  • WBC \>3x10\^9/l, lymphocytes \>0.8x10\^9/l, platelets \>100x10\^9/l, serum creatinine \<150 µmol/l, serum bilirubin \<25 µmol/l
  • normal serum LDH (\<450 U/l)
  • expected adequacy of follow-up
  • no pregnant or lactating women
  • written informed consent
  • and in addition: Stage III melanoma
  • radical regional lymphnode dissection is performed Stage IV melanoma
  • +1 more criteria

You may not qualify if:

  • any prior chemotherapy, immunotherapy or radiotherapy is allowed if completed more than 4 weeks prior to planned vaccination
  • history of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix
  • serious active infections, known HbsAg or HIV positive, or autoimmune diseases or organ allografts
  • concomitant use of immunosuppressive drugs
  • known allergy to shell fish (since it contains KLH)
  • rapidly progressive symptomatic disease
  • any serious clinical condition that may interfere with the safe administration of DC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Melanoma

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Winette van der Graaf, professor

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2013

First Posted

November 7, 2014

Study Start

February 1, 2011

Primary Completion

October 1, 2015

Study Completion

April 1, 2016

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

NL(1)