AzTrials
AzTrials

MelanomaPhase 1NCT01066390

A Study on the Safety and Immunogenicity of Combined Intradermal and Intravenous Administration of an Autologous mRNA Electroporated Dendritic Cell Vaccine in Patients With Previously Treated Unresectable Stage III or IV Melanoma

A Phase 1 study testing TriMix-DC in people with Melanoma, run by Bart Neyns at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase I study plan is divided in the following four phases: Eligibility Screen Phase (week -4 to -1): Following written informed consent patients with metastatic melanoma (AJCC stage III/IV with unresectable disease) will undergo an eligibility screen (incl. blood analysis and PET/CT-scan). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
TriMix-DC
How many people
18 participants
Where
1 siteBelgium
Study dates
Dec 2009to May 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able and willing to give valid written informed consent before undergoing any study-related activities.
  • Patients with histological documentation of AJCC stage III or IV melanoma of the skin, mucosa, eye or unknown primary.
  • Unable to undergo resection of all metastatic disease.
  • Negative serology for HBV, HCV, HIV and Syphilis. If positive results for HepB or Syphilis indicate immunity and are not indicative of active infection, the patient can enter the study.
  • Adequate venous access that allows to undergo leucapheresis.
  • Having failed first line treatment with DTIC based chemotherapy
Show all 13Show fewer
  • Full recovery from all prior therapies. A minimum of 4 weeks (6 weeks in case of prior treatment with nitrosurea or Mitomycin C) should separate the last day of prior treatment administration and the date of informed consent.
  • WHO performance status of 0, 1 or 2 (see Appendix D).
  • Male and female patients ≥ 18 years of age.
  • Laboratory parameters should be within normal range, except for the following laboratory parameters, which must be within the ranges specified:see protocol.
  • Viral tests:HIV,HBV and HCV
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study.
  • Patients must be willing to cooperate for the whole period of the study.

Who cannot join

  • Evidence of immunodeficiency. Autoimmune disease requiring medical treatment
  • Any serious acute or chronic illnesses or other conditions requiring concurrent medications not allowed during this study.
  • History of malignancy.
  • Inability to undergo PET/CT or MRI examination.
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
Show all 12Show fewer
  • Subject is pregnant or is currently breast-feeding, anticipates becoming pregnant/ impregnating their partner during the study or within 6 months after study participation, or subject does not agree to follow acceptable methods of birth control, such as hormonal contraception, intra-uterine pessary, condoms or sterilization, to avoid conception during the study and for at least 6 months after receiving the last dose of study treatment.
  • Current alcohol dependence or drug abuse.
  • Known hypersensitivity to the study treatment.
  • Legal incapacity or limited legal capacity.
  • Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZ Brussel

    Laken, Brussels Capital, 1090

Other trials in Belgium

About this study

This phase I study plan is divided in the following four phases:

  • Eligibility Screen Phase (week -4 to -1): Following written informed consent patients with metastatic melanoma (AJCC stage III/IV with unresectable disease) will undergo an eligibility screen (incl. blood analysis and PET/CT-scan).
  • TriMix-DC Vaccine Manufacturing Phase (week I to IV): eligible patients will undergo a leucapheresis (15 liter of venous blood) for the preparation of autologous TriMix-DC vaccine. Vaccine preparations will be manufactured and quality-controlled (during an interval of 4 weeks following the leucapheresis) and released for patient administration if the TriMix-DC preparation fulfills the predefined quality requirements.
  • TriMix-DC Vaccine Administration Phase (Week 1 to 24): 4 weeks after the leucapheresis patients will initiate therapeutic vaccination with the TriMix-DC vaccine by IV and ID administration. The vaccines will be administered at 4 different visits that will be separated with an interval of 2 weeks. At each vaccination a total of 12.106 DC per antigen will be administered.
  • Patients will be allocated to three different cohorts:
  • The first cohort will receive 10% of TriMix-DC by iv and 90% by id injection.
  • The second cohort 25% by iv and 75% by id injection.
  • The third cohort 50% by iv and 50% by id injection.
  • During the week following the administration of the fourth vaccine (= week 8), a DTH-test and punch biopsy of the injection site will be performed as well as a second leucapheresis (for the purpose of immuno-monitoring) and tumor evaluation (by PET-CT).
  • A fifth vaccine will be administered and a repeat tumor staging performed in week 16 (= 8w after the fourth vaccine).
  • End of study visit: Patients will perform an "end of study visit" 8 weeks after the fifth vaccine (= week 24) as well as a new tumor evaluation (PET/CT).
  • Follow-up Phase: survival data will be obtained until 3 years after the initiation of vaccine therapy or the time of death.
Conditions
Melanoma
Being tested
TriMix-DC
Keywords
stage IIIC/IV melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TriMix-DCBiological

    eligible patients will undergo a leucapheresis for the preparation of autologous TriMix-DC vaccine.4 weeks after the leucapheresis patients will initiate therapeutic vaccination with the TriMix-DC vaccine by IV and ID administration. The vaccines will be administered at 4 different visits that will be separated with an interval of 2 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. a new tumor evaluation (PET/CT)

    Measured: 24 weeks

Secondary outcomes (1)

  1. Document the anti-melanoma activity

    Measured: week 8, 16 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionNov 2013
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01066390
Sponsor's protocol ID
2009-015748-40
Other IDs
2009
Status last verified
Aug 2012
First submitted
8 Jan 2010
Last updated
6 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • Wilgenhof S, Van Nuffel AMT, Benteyn D, Corthals J, Aerts C, Heirman C, Van Riet I, Bonehill A, Thielemans K, Neyns B. A phase IB study on intravenous synthetic mRNA electroporated dendritic cell immunotherapy in pretreated advanced melanoma patients. Ann Oncol. 2013 Oct;24(10):2686-2693. doi: 10.1093/annonc/mdt245. Epub 2013 Jul 31.

    PubMed 23904461

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TriMix-DC in people with Melanoma, run by Bart Neyns at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

a new tumor evaluation (PET/CT) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01066390, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in