Dendritic CellsPhase 1/2NCT03114631

Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

A Phase 1/2 study testing Dendritic cells pulsed with tumor lysate and Dendritic cells pulsed with MUC-1/WT-1 peptides in people with Dendritic Cells and Pancreatic Neoplasms, run by The Republican Research and Practical Center for Epidemiology and Microbiology at 1 site in Belarus.

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

The trial evaluates the safety and efficacy of MUC-1/WT-1 peptide and/or tumor lysate-pulsed dendritic cell Immunotherapy for the patients with pancreatic cancer Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Dendritic Cells, Pancreatic Neoplasms
What is being tested?: Dendritic cells pulsed with tumor lysate and Dendritic cells pulsed with MUC-1/WT-1 peptides
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteBelarus
Study dates: 9 Jan 2017to 23 May 2019
Phase: Phase 1/2
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

histologically or cytologically confirmed pancreatic cancer (adenocarcinoma);
HLA-A2 expression by tumor cells;
WT-1/MUC-1 expression by tumor cells.

Who cannot join

refuse of patient to participate in the trial;
pregnancy/lactation;
intercurrent severe chronic diseases;
HIV, Hepatites B/C;
active tuberculosis;
alcohol use disorder/drug addiction.

Trial locations and contacts

1 site in 1 country.

Belarus1 site

Minsk City Clinical Oncologic Dispensary
Minsk, 220000

Other trials in Belarus

About this study

Official title: Single-center Trial Evaluating the Safety and Efficacy of MUC-1/WT-1 Peptide or Tumor Lysate-pulsed Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

The trial evaluates the safety and efficacy of MUC-1/WT-1 peptide and/or tumor lysate-pulsed dendritic cell Immunotherapy for the patients with pancreatic cancer

Read the detailed description

The trial evaluates the safety and efficacy of dendritic cell Immunotherapy for the patients with pancreatic cancer. Dendritic cells are obtained from blood monocytes using standard protocol.

Two options for dendritic cell priming are used: MUC-1/WT-1 peptides for the patients with unresectable tumor and/or tumor lysates for the patients undergoing tumor resection.

The dendritic cells are them matured and injected subcutaneous (all patients) and intratumorally (when possible).

Conditions: Dendritic Cells, Pancreatic Neoplasms
Being tested: Dendritic cells pulsed with tumor lysate, Dendritic cells pulsed with MUC-1/WT-1 peptides
Keywords: dendritic cells, pancreatic cancer, immunotherapy
Medical subject headings: Pancreatic Neoplasms

What participants receive

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

Dendritic cells pulsed with tumor lysateBiological
Dendritic cells pulsed with MUC-1/WT-1 peptidesBiological

Study groups in NCT03114631
Study group	Role	What they receive
Dendritic cells lysate-pulsed group	Experimental	Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate Receives: Biological: Dendritic cells pulsed with tumor lysate
Control group	No intervention	Patients treated according to clinical protocols
Dendritic cells peptide-pulsed group	Experimental	Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with MUC-1/WT-1 peptides Receives: Biological: Dendritic cells pulsed with MUC-1/WT-1 peptides

What is being measured

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

Number of Participants with PR or CR at 1 year
1 year PR/CR
Measured: 1 year
Number of Participants Who Survived at 1 Year
1 year overall survival
Measured: 1 year

Secondary outcomes (5)

Antigen-specific immune response
The increase of antigen-specific T-cells
Measured: 1 year
Circulating tumor cells count
Decrease of EpCAM+CD45- circulating tumor cells count
Measured: 1 year
Immune response
Decrease of T-regulatory cells
Measured: 1 year
Number of Participants Who Survived at 2 Years
2 year overall survival
Measured: 2 years
Number of Participants Who Survived at 3 Years or more
3 year overall survival
Measured: 3 years

Timeline

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

9 Jan 201723 May 2019

First posted14 Apr 2017
Study start9 Jan 2017
Primary completion3 May 2019
Study completion23 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dendritic CellsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03114631
Sponsor's protocol ID: RRPCEM_DC1
Status last verified: Dec 2019
First submitted: 11 Apr 2017
Last updated: 3 Dec 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer.
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All Dendritic Cells trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-center Trial Evaluating the Safety and Efficacy of MUC-1/WT-1 Peptide or Tumor Lysate-pulsed Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer
ClinicalTrials.gov ID: NCT03114631
Acronym / sponsor ID: RRPCEM_DC1
Conditions: Dendritic Cells, Pancreatic Neoplasms
Keywords: dendritic cells, pancreatic cancer, immunotherapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: The Republican Research and Practical Center for Epidemiology and MicrobiologyUniversity, hospital or other
Collaborators: Belarusian State Medical University
Study start: 9 Jan 2017 (actual)
Primary completion: 3 May 2019 (actual)
Study completion: 23 May 2019 (actual)
First posted: 14 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The trial evaluates the safety and efficacy of MUC-1/WT-1 peptide and/or tumor lysate-pulsed dendritic cell Immunotherapy for the patients with pancreatic cancer

Detailed description

The trial evaluates the safety and efficacy of dendritic cell Immunotherapy for the patients with pancreatic cancer. Dendritic cells are obtained from blood monocytes using standard protocol.

Two options for dendritic cell priming are used: MUC-1/WT-1 peptides for the patients with unresectable tumor and/or tumor lysates for the patients undergoing tumor resection.

The dendritic cells are them matured and injected subcutaneous (all patients) and intratumorally (when possible).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dendritic cells lysate-pulsed group	Experimental	Biological: Dendritic cells pulsed with tumor lysatePatients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate
Control group	No intervention	–Patients treated according to clinical protocols
Dendritic cells peptide-pulsed group	Experimental	Biological: Dendritic cells pulsed with MUC-1/WT-1 peptidesPatients treated according to clinical protocols plus autologous dendritic cells, pulsed with MUC-1/WT-1 peptides

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

histologically or cytologically confirmed pancreatic cancer (adenocarcinoma);
HLA-A2 expression by tumor cells;
WT-1/MUC-1 expression by tumor cells.

Key exclusion criteria (6 listed)

refuse of patient to participate in the trial;
pregnancy/lactation;
intercurrent severe chronic diseases;
HIV, Hepatites B/C;
active tuberculosis;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dendritic cells pulsed with tumor lysate	Biological	Dendritic cells lysate-pulsed group
Dendritic cells pulsed with MUC-1/WT-1 peptides	Biological	Dendritic cells peptide-pulsed group

Primary outcome

Number of Participants with PR or CR at 1 year
Time frame: 1 year
1 year PR/CR
Number of Participants Who Survived at 1 Year
Time frame: 1 year
1 year overall survival

5 secondary outcomes

Antigen-specific immune response
Time frame: 1 year
Circulating tumor cells count
Time frame: 1 year
Immune response
Time frame: 1 year
Number of Participants Who Survived at 2 Years
Time frame: 2 years
Number of Participants Who Survived at 3 Years or more
Time frame: 3 years

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
Individual participant dataSharing planned: Undecided

Related trials for Dendritic Cells

RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
RecruitingPhase 1/2
Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer
Endometrial Cancer, Cancer of Endometrium
Not yet recruitingPhase 1
Engineered Dendritic Cell Vaccines for Multiple Myeloma
Multiple Myeloma or Plasmacytoma
Active, not recruitingPhase 2
Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer.
Stage IV Colorectal Cancer, Curative Resection
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexander V. Prokharau, Prof. study director

Belarussian State Medical University, Minsk, Belarus

Andrei Y Hancharou, Dr. study director

The Republican Research and Practical Center for Epidemiology and Microbiology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 6 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 3 Dec 2019. 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 Belarus. 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 combined 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.

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?

Number of Participants with PR or CR at 1 year (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT03114631.

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 3 Dec 2019.