Pancreatic Adenocarcinoma Non-resectablePhase 1NCT01677962
A Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Pancreatic Adenocarcinoma
A Phase 1 study testing Poly-ICLC and dendritic cell in people with Pancreatic Adenocarcinoma Non-resectable, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The main purpose of this study is to examine the safety of the study drug in patients with locally advanced unresectable pancreatic adenocarcinoma. The study team would like to know about any side effects a patient may have when given the study drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma Non-resectable
- What is being tested?
- Poly-ICLC and dendritic cell
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to May 2016
- 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
- Each of the following criteria must be met in order for a patient to be considered eligible for enrollment.
- Patients must have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma that is locally advanced and unresectable. Patients with endocrine or neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible.
- Patients must have measurable disease per RECIST 1.1. One or more tumors measurable on CT scan per RECIST 1.1. (Eisenhauer)
- Patients may have had prior cancer therapy. Patients do not need to demonstrate progression to be considered for this trial.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Age ≥ 18 years.
Show all 17Show fewer
- Patient must have an expected life expectancy greater than 3 months.
- Signed, written IRB-approved informed consent.
- Bilirubin ≤ 3 times upper limit of normal (CTCAE Grade 2 baseline)
- AST (SGOT), ALT (SGPT) ≤ 3 x ULN (CTCAE Grade 1 baseline)
- Serum creatinine ≤1.5 XULN (CTCAE Grade 1 baseline)
- Acceptable hematologic status, defined as:
- Absolute neutrophil count ≥ 1000 cells/mm3
- Platelet count ≥ 75,000 (plt/mm3), (CTCAE Grade 1 baseline)
- Hemoglobin ≥ 9 g/dL.
- Urinalysis with no clinically significant abnormalities.
- PT and PTT ≤ 1.5 X ULN after correction of nutritional deficiencies that may contribute to prolonged PT/PTT
Who cannot join
- Each of the following criteria should not be present in order for the patient to be considered eligible for enrollment.
- Patients must not have metastatic disease. Patients with evidence of metastatic disease at the time of screening or prior to the administration of DC vaccination will be considered a screen failure and excluded from study.
- Prior surgery is allowed provided at least 14 days has elapsed between surgery and registration. Prior radiation/chemo is allowed provided that at least 28 days have elapsed since the last treatment.
- Patients must not have any serious uncontrolled acute or chronic medical condition that would interfere with this treatment. Examples would include active acute or chronic infection requiring antibiotics, uncontrolled cardiovascular, endocrine, or infectious disease.
- Patient must not have clinically significant ascites.
- 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.
Show all 10Show fewer
- 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 brainimaging 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 of child bearing potential must have a negative pregnancy test completed during study screening. 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
About this study
Official title: A Feasibility and Safety Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma
The main purpose of this study is to examine the safety of the study drug in patients with locally advanced unresectable pancreatic adenocarcinoma. The study team would like to know about any side effects a patient may have when given the study drug. Another goal of the study is to determine if combining dendritic cells and the study drug can be possibly used as a vaccine for this disease. Dendritic cells are cells that are present in the body's immune system that help your body fight disease.
- Conditions
- Pancreatic Adenocarcinoma Non-resectable
- Being tested
- Poly-ICLC, dendritic cell
- Keywords
- locally advanced, unresectable pancreatic adenocarcinoma, Poly ICLC, dendritic cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-ICLCBiological
dendritic cellBiological
| Study group | Role | What they receive |
|---|---|---|
| dendritic cell and Poly-ICLC vaccination | Experimental | Dendritic cell and Poly-ICLC vaccination will be administered directly into the tumor on Day 0 and Day 14 of Treatment Phase. Subjects will then have standard of care procedures along with injections of Poly-ICLC and dendritic cells for the remainder of the study. Receives: Biological: Poly-ICLC; Biological: dendritic cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Number of Participants With Adverse Events (AEs)
Evaluate the frequency of toxicities by type and severity, and dose of study drug according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Measured: from study consent to last treatment (Day 56)
Primary Objective
Determining the feasibility of generating dendritic cells and administering these cells as a vaccine to patients
Measured: from study consent to last treatment (Day 56)
Secondary outcomes (2)
Secondary Outcome
Number of Participants With Tumor Response
Measured: Average three months Per Participant
Secondary Objective
Measure overall Survival
Measured: Post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Adenocarcinoma Non-resectableStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Britten, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677962
- Sponsor's protocol ID
- 101778
- Status last verified
- Dec 2016
- First submitted
- 17 Aug 2012
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Safety Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01677962
- Acronym / sponsor ID
- 101778
- Conditions
- Pancreatic Adenocarcinoma Non-resectable
- Keywords
- locally advanced, unresectable pancreatic adenocarcinoma, Poly ICLC, dendritic cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Sep 2012 (estimated)
- 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 main purpose of this study is to examine the safety of the study drug in patients with locally advanced unresectable pancreatic adenocarcinoma. The study team would like to know about any side effects a patient may have when given the study drug. Another goal of the study is to determine if combining dendritic cells and the study drug can be possibly used as a vaccine for this disease. Dendritic cells are cells that are present in the body's immune system that help your body fight disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dendritic cell and Poly-ICLC vaccination | Experimental | Biological: Poly-ICLC, Biological: dendritic cellDendritic cell and Poly-ICLC vaccination will be administered directly into the tumor on Day 0 and Day 14 of Treatment Phase. Subjects will then have standard of care procedures along with injections of Poly-ICLC and dendritic cells for the remainder of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Each of the following criteria must be met in order for a patient to be considered eligible for enrollment.
- Patients must have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma that is locally advanced and unresectable. Patients with endocrine or neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible.
- Patients must have measurable disease per RECIST 1.1. One or more tumors measurable on CT scan per RECIST 1.1. (Eisenhauer)
- Patients may have had prior cancer therapy. Patients do not need to demonstrate progression to be considered for this trial.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Key exclusion criteria (10 listed)
- Each of the following criteria should not be present in order for the patient to be considered eligible for enrollment.
- Patients must not have metastatic disease. Patients with evidence of metastatic disease at the time of screening or prior to the administration of DC vaccination will be considered a screen failure and excluded from study.
- Prior surgery is allowed provided at least 14 days has elapsed between surgery and registration. Prior radiation/chemo is allowed provided that at least 28 days have elapsed since the last treatment.
- Patients must not have any serious uncontrolled acute or chronic medical condition that would interfere with this treatment. Examples would include active acute or chronic infection requiring antibiotics, uncontrolled cardiovascular, endocrine, or infectious disease.
- Patient must not have clinically significant ascites.
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 |
|---|---|---|
| Poly-ICLC | Biological | dendritic cell and Poly-ICLC vaccination |
| dendritic cell | Biological | dendritic cell and Poly-ICLC vaccination |
Primary outcome
Primary Outcome
Time frame: from study consent to last treatment (Day 56)
Number of Participants With Adverse Events (AEs) Evaluate the frequency of toxicities by type and severity, and dose of study drug according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Primary Objective
Time frame: from study consent to last treatment (Day 56)
Determining the feasibility of generating dendritic cells and administering these cells as a vaccine to patients
2 secondary outcomes
Secondary Outcome
Time frame: Average three months Per Participant
Secondary Objective
Time frame: Post treatment
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 15 Dec 2016.
Related trials for Pancreatic Adenocarcinoma Non-resectable
RecruitingPhase 1
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
Solid Tumor, Non-Small-Cell Lung Cancer
RecruitingPhase 2
SMAD4 Tailored Neoadjuvant Therapy for the Treatment of Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma, SMART-PANC Trial
Borderline Resectable Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma
Recruiting
Adaptive Radiation for Locally Advanced Unresectable Pancreatic Cancer
Locally Advanced Pancreatic Ductal Adenocarcinoma (PDA)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Poly-ICLC and dendritic cell in people with Pancreatic Adenocarcinoma Non-resectable, run by Medical University of South Carolina 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 17 inclusion and 10 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 15 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?
Primary Outcome (time frame: from study consent to last treatment (Day 56)). 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?
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 15 Dec 2016.