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Malignant Melanoma Stage IIIPhase 2DC-MELNCT01676779

mRNA Electroporated Autologous Dendritic Cells for Stage III/IV Melanoma

A Phase 2 study testing Dendritic cell therapy in people with Malignant Melanoma Stage III and Malignant Melanoma Stage IV, run by Universitair Ziekenhuis Brussel 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
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Trial summary

This is an open label, 2-arm, 1-stage, randomized controlled phase II study in patients with AJCC stage IIIB/C \& -IV melanoma. At baseline tumor assessment (using total body FDG-PET/CT), patients should be free from measurable tumor lesions (according to RECISTv1.1 definitions) following prior local therapy (e.g. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dendritic cell therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteBelgium
Study dates
Oct 2012to Sep 2016
Phase
Phase 2
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 written informed consent
  • Histological documentation of AJCC stage III or stage IV melanoma
  • melanoma (melanoma originating in the choroid, iris or ciliar body are not eligible)
  • baseline tumor assessment by whole-body FDG-PET/CT, patients should be free from measurable tumor lesions (RECIST (v1.1)), and free from symptomatic non-measurable tumor lesions
  • Prior local treatment of primary and metastatic tumor lesions is allowed . Treated tumor lesions should be free from progression at baseline assessment
  • Normal organ function and normal hematological parameters;laboratory parameters should be within normal range, except following laboratory parameters:HEMOGLOBIN ≥ 10 G/DL; GRANULOCYTES ≥ 1,500/µL; LYMPHOCYTES ≥ 1000/µL; PLATELETS ≥ 100,000/µL; SERUM CREATININ ≤ 2.0 MG/DL; SERUM BILIRUBIN ≤ 2.0 MG/DL; AST AND ALT ≤ 2 X THE NORMAL UPPER LIMITS; LDH ≤ 1,5X NORMAL UPPER LIMIT; CRP ≤ 1,5X NORMAL UPPER LIMIT; PROTHROMBIN TIME (PT) INTERNATIONAL NORMALIZED RATIO (INR) AND PARTIAL THROMBOPLASTIN TIME (PTT) WITHIN NORMAL LIMITS
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  • Negative serology for HCV, and HIV; absence of active infection with HBV, 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(to undergo leukapheresis)
  • No prior systemic therapy for melanoma
  • Full recovery from all prior therapies. A period of 4 weeks following major surgery, radiation therapy, or ILP, or any other major invasive procedure is required
  • Baseline WHO performance status of 0 or 1
  • Male and female patients ≥ 18 years
  • No need for uninterrupted therapeutic anticoagulation
  • No prior history of a serious autoimmune disorder
  • No concomitant medication with immune suppressive drugs
  • Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study in such a manner that the risk of pregnancy is minimized.

Who cannot join

  • Evidence of immunodeficiency or autoimmune disease requiring medical treatment (e.g. corticosteroids or other immunosuppressive drugs).Vitiligo is not an exclusion criterion
  • Any serious acute or chronic illnesses (e.g. heart disease NYHA Class III or IV,renal-,liver- or pulmonary insufficiency) or other conditions requiring concurrent medications not allowed during this study (e.g. active chronic infections requiring antibiotics)
  • History of malignancy. Curatively treated cervical carcinoma in situ,or squamous-,or basal cell carcinoma of the skin, or subjects who have been treated and recurrence-free of other malignancies for more than 5 years following the diagnosis are eligible
  • Inability to undergo FDG-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
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  • Subject is pregnant (positive serum beta-HCG test at screening) 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, 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

    Brussels, 1090

Other trials in Belgium

About this study

Official title: Randomized Controlled Phase II Clinical Trial on mRNA Electroporated Autologous Dendritic Cells for Stage III/IV Melanoma Patients Who Are Disease-free Following the Local Treatment of Macrometastases.

This is an open label, 2-arm, 1-stage, randomized controlled phase II study in patients with AJCC stage IIIB/C \& -IV melanoma. At baseline tumor assessment (using total body FDG-PET/CT), patients should be free from measurable tumor lesions (according to RECISTv1.1 definitions) following prior local therapy (e.g. following surgical resection, isolated limb perfusion, radiofrequency ablation, cryotherapy, radiotherapy, electrochemotherapy, …). Patients should not have symptomatic non-measurable tumor lesions (e.g. bone metastasis, or pleural effusion), and lesions treated by prior local therapy should be free from progression. Patients should not have received any prior systemic therapy (non-experimental or experimental).

Read the detailed description

This is an open label, 2-arm, 1-stage, randomized controlled phase II study in patients with AJCC stage IIIB/C \& -IV melanoma. At baseline tumor assessment (using total body FDG-PET/CT), patients should be free from measurable tumor lesions (according to RECISTv1.1 definitions) following prior local therapy (e.g. following surgical resection, isolated limb perfusion, radiofrequency ablation, cryotherapy, radiotherapy, electrochemotherapy, …). Patients should not have symptomatic non-measurable tumor lesions (e.g. bone metastasis, or pleural effusion), and lesions treated by prior local therapy should be free from progression. Patients should not have received any prior systemic therapy (non-experimental or experimental).

  • Patients will be randomized between two treatment arms (Arm-A and -B). In study Arm-A, patients will receive DC-administrations during one year following randomization. Salvage treatment by local therapies will be allowed during the study treatment in Arm-A. In study Arm-B, patients will initiate DC-administrations only after documented recurrence of the melanoma that cannot be salvaged by local therapy.
  • The primary endpoint of this clinical trial is to determine the rate (%) of patients who are free from macrometastases (: measurable tumor lesions and symptomatic non-measurable tumor lesions) at 1-year (= 52 weeks) after randomization.

Patients treated on Arm-B will serve as a contemporary control-arm to help interpreting the outcome of patients treated in Arm-A. By design (phase II) this trial will not be powered to statistically prove a predefined difference between the two study arms (this would require a phase III design). Patients treated in Arm-B will be able to initiate immunotherapy with autologous DC at the time of recurrence that can not be salvaged by local therapy. Documentation of the anti-tumor activity and survival following DC-treatment at recurrence in Arm-B patients will be a secondary objective of this clinical trial.

Being tested
Dendritic cell therapy
Keywords
melanoma, no evidence of disease, resection, macro-metastases
Medical subject headings
Melanoma

What participants receive

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

  • Dendritic cell therapyBiological

    Dendritic cell therapy IV and ID

Study groups in NCT01676779
Study groupRoleWhat they receive
Arm A dendritic cell therapyExperimentalArm-A, patients will receive Dendritic Cell therapy during one year following randomization.
Receives: Biological: Dendritic cell therapy
Arm B Dendritic cell therapyExperimentalArm-B, patients will initiate Dendritic Cell therapy only after documented recurrence of the melanoma that cannot be salvaged by local therapy.
Receives: Biological: Dendritic cell therapy

What is being measured

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

  1. 1-year disease free survival percentage

    Patients will be evaluated 52 weeks following randomization for their melanoma disease status (= macro-metastases present or absent)

    Measured: 1-year following recruitment date

Secondary outcomes (1)

  1. safety

    Patients will be followed continuous during their study participation for adverse events

    Measured: continuous during the study (52weeks after start)

Timeline

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

  1. First posted31 Aug 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionSep 2015
  4. Study completionSep 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01676779
Sponsor's protocol ID
DC-MEL
Acronym
DC-MEL
Status last verified
May 2017
First submitted
21 Aug 2012
Last updated
24 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dendritic cell therapy in people with Malignant Melanoma Stage III and Malignant Melanoma Stage IV, run by Universitair Ziekenhuis Brussel 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 16 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 24 May 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

1-year disease free survival percentage (time frame: 1-year following recruitment date). 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 NCT01676779.

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 24 May 2017.

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