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Metastatic Pancreatic CancerPhase 1NCT01410968

A Feasibility and Safety Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells in Patients With Metastatic, Locally Advanced, Unresectable, or Recurrent Pancreatic Adenocarcinoma

A Phase 1 study testing vacc. w/ Poly-ICLC & peptide-pulsed dendritic cells in people with Metastatic Pancreatic Cancer, run by Carolyn Britten at 1 site in United States.

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 purpose of this study is to provide a safety and feasibility basis for future studies addressing the hypothesis that subcutaneous vaccination with dendritic cells loaded with multiple antigenic epitopes expressed by pancreatic tumor in combination with systemic administration of Poly-ICLC (Hiltonol) will induce… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
vacc. w/ Poly-ICLC & peptide-pulsed dendritic cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Aug 2011to May 2015
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

None listed.

Who cannot join

  • Patients must not have any serious uncontrolled acute or chronic medical condition that would interfere with this treatment. An example would be an active acute or chronic infection requiring antibiotics
  • Patients must not have significant ongoing cardiac problems, myocardial infarction within the last six months, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia or congestive heart failure.
  • Patients with known brain metastases are not eligible. However, brain-imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms. If brain-imaging studies are performed, they must be negative for disease.
  • Patients must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol treatment.
  • Due to the undetermined effect of this treatment regimen in patients with HIV-1 infection and the potential for serious interaction with anti-HIV medications, patients known to be infected with HIV are not eligible for this study.
  • Due to the possibility of harm to a fetus or nursing infant from this treatment regimen, patients must not be pregnant or nursing. Women and men of reproductive potential must have agreed to use an effective contraceptive method.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

The purpose of this study is to provide a safety and feasibility basis for future studies addressing the hypothesis that subcutaneous vaccination with dendritic cells loaded with multiple antigenic epitopes expressed by pancreatic tumor in combination with systemic administration of Poly-ICLC (Hiltonol) will induce anti-tumor immunity.

Read the detailed description

Primary Objectives

  1. Assess the safety of this treatment by evaluating the qualitative and quantitative toxicities in this group of patients.
  2. Determine the feasibility of generating dendritic cells and administering these cells as a vaccine to patients.

Secondary Objectives

  1. Assess anti-tumor activity after vaccination, measured by change in tumor burden and overall survival.
  2. Assess immunological responses after vaccination (antigen-specific T cell cytokine production, antigen-specific T cell frequencies by tetramer analysis, and DTH reactions)
Being tested
vacc. w/ Poly-ICLC & peptide-pulsed dendritic cells
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • vacc. w/ Poly-ICLC & peptide-pulsed dendritic cellsDrug

    Intradermal injection of 1x107 peptide-pulsed dendritic cells followed by intramuscular injection of 30 micrograms per kilogram Poly-ICLC on days 0, 14, 28 and 42. Additional dose of 30 micrograms per kilogram Poly-ICLC on days 3, 17, 31 and 45. Treatment given via one 56-day cycle. Leukapheresis performed at baseline for dendritic cell generation.

Study groups in NCT01410968
Study groupRoleWhat they receive
VaccinationExperimentalvaccination with investigational Poly-ICLC \& peptide-pulsed dendritic cells
Receives: Drug: vacc. w/ Poly-ICLC & peptide-pulsed dendritic cells

What is being measured

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

  1. Feasibility

    Any protocol deviations will be described and the protocol schedule will be re-assessed to improve feasibility of implementation if necessary. The proportion of patients successfully completing the protocol (i.e., without deviations) will be reported with a one-sided 90% confidence interval. If the observed feasibility rate is >0.80, the lower limit will be no lower than 0.60.

    Measured: 2 years

  2. Safety

    All toxicities will be reported by type and grade and tabulated. To provide a safety characterization of the treatment regimen, it is important that common toxicities be observed in this phase of study for planning the next phase of research.

    Measured: 2 Years

Secondary outcomes (2)

  1. Efficacy

    Graphical displays of tumor size (as a percentage of baseline) over time. A subject's best response (i.e., complete response, partial response, stable disease or progressive disease) will be reported. Time to disease progression from baseline for each patient will be reported. Time to death will be reported in the same manner. These results will be summarized using proportions with confidence intervals and Kaplan-Meier curves, although the confidence limits are expected to be wide based on the small sample size.

    Measured: 2 years

  2. Immunological Responses

    Antigen-specific T cell frequencies, antigen-specific T cell cytokine production and DTH reactions will be assessed.

    For T cell-based functional analysis, each measurement will be performed with the three peptides telomerase, CEA, and survivin. Transformation of the continuous outcomes will be logged. Post measurements will be normalized by the baseline value (i.e. we will subtract the baseline value from each of the post vaccination measurements after the log transformations). Each of these measures will be displayed graphically over time for each patient to observe modulations in these measures. If appropriate based on the distribution of values over time, linear longitudinal regression will be used to model the change in these outcomes over time. Appropriateness will be based on the consistency of trends across patients.

    Measured: 2 years

Timeline

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

  1. First posted5 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionNov 2013
  4. Study completionMay 2015

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01410968
Sponsor's protocol ID
101498
Status last verified
Dec 2016
First submitted
4 Aug 2011
Last updated
9 Dec 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Mehrotra S, Britten CD, Chin S, Garrett-Mayer E, Cloud CA, Li M, Scurti G, Salem ML, Nelson MH, Thomas MB, Paulos CM, Salazar AM, Nishimura MI, Rubinstein MP, Li Z, Cole DJ. Vaccination with poly(IC:LC) and peptide-pulsed autologous dendritic cells in patients with pancreatic cancer. J Hematol Oncol. 2017 Apr 7;10(1):82. doi: 10.1186/s13045-017-0459-2.

    PubMed 28388966

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing vacc. w/ Poly-ICLC & peptide-pulsed dendritic cells in people with Metastatic Pancreatic Cancer, run by Carolyn Britten at 1 site in United States.

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 0 inclusion and 7 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 9 Dec 2016. 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 United States. 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?

Feasibility (time frame: 2 years). 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 NCT01410968, 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 9 Dec 2016.

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