Pancreatic CancerPhase 1PancVaxNCT02548169
Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer
A Phase 1 study of Pancreatic Cancer, run by Baylor Research Institute at 1 site in United States.
Trial summary
The primary objective is to confirm clinical safety and feasibility of combining the antigen-loaded Dendritic Cell (DC) vaccine with chemotherapy including folinic acid, oxaliplatin, irinotecan and 5-Fluorouracil (5FU) (FOLFIRINOX) and nab-paclitaxel/gemcitabine in patients with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 24 Apr 2017
- 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
- Suspected pancreatic ductal adenocarcinoma (PDAC) prior to diagnosis or histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology.
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.
- Serum Albumin greater than or equal to 2.0 gm/dL
- Expected survival greater than or equal to 6 months.
- Adequate hematologic function as defined by
- Absolute Neutrophil Count (ANC) greater than 1500/mm^3
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- Platelets greater than or equal to 70,000/mm^3
- Hemoglobin greater than 9 g/dL
- Adequate liver function, as defined by:
- Serum Total Bilirubin less than or equal to 2 x Upper limit of normal (ULN) mg/dL
- Alanine transaminase (ALT) and Aspartate transaminase (AST) less than or equal to 2.5x Upper limit of normal (ULN)
- Serum Creatinine less than or equal to 2 x Upper limit of normal (ULN) or creatinine clearance greater than or equal to 30 ml/min
- All females of child bearing potential must agree to use contraception to avoid pregnancy throughout the study and for 1 month after the last DC vaccination.
- Subjects must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate. Subjects may not be consented by a medical power of attorney.
- Subject must be accessible for treatment and follow up.
Who cannot join
- History of Organ transplant
- Other malignancy within 5 years, unless the probability of recurrence of the prior malignancy is <5% as determined by the principal investigator.
- Current, active immunosuppressive therapy such as cyclosporine, tacrolimus
- Subjects taking chronic systemic corticosteroid therapy for any reason are not eligible. Subjects may receive steroids as prophylactic anti-emetics, not toe exceed 10mg Decadron weekly. Subjects receiving inhaled or topical corticosteroids are eligible. Subjects who require chronic systemic corticosteroids after beginning vaccination will be removed from the study.
- Significant or uncontrolled congestive heart failure, myocardial infarction or significant ventricular arrhythmias within the last 6 months
- Active infection or antibiotics within 48 hours prior to study enrollment, including unexplained fever
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- Autoimmune disease ( e.g. systemic lupus erythematosis, rheumatoid arthritis). Subjects with remote history of asthma or mild active asthma are eligible.
- Other severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
- Severe impaired lung functions as defined by spirometry and diffusing capacity of lung for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
- Uncontrolled diabetes as defined by fasting serum glucose >250 mg/dL
- Live disease such as cirrhosis or severe hepatic impairment (child pugh class C)
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or quality of the data.
- Other investigational or anti-cancer treatments while participating in this study.
- Other active cancer
- Women who are pregnant or breastfeeding
- Known to be HIV positive
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles A. Sammons Cancer Center
Dallas, Texas, 75246
About this study
Official title: A Phase I, Safety Trial of Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer
The primary objective is to confirm clinical safety and feasibility of combining the antigen-loaded Dendritic Cell (DC) vaccine with chemotherapy including folinic acid, oxaliplatin, irinotecan and 5-Fluorouracil (5FU) (FOLFIRINOX) and nab-paclitaxel/gemcitabine in patients with pancreatic cancer.
The secondary objectives of this trial are to determine preliminary clinical efficacy based on response rates, overall survival and progression free survival compared with historic control, and surgical conversion rate as defined as percent of locally advanced (unresectable) patients achieving resectability within 6 months of treatment initiation. Also, to identify vaccine immunogenicity by measuring acquired, T cell-mediated immune activating events post-vaccination and to correlate clinical response with acquired immune responses.
Read the detailed description
This is a single center, exploratory pilot safety, open label, phase I trial that will evaluate the combination of DC vaccination in 2 groups of patients when combined with chemotherapy including FOLFIRINOX and gemcitabine+nab-paclitaxel in patients with pancreatic cancer. The investigations will accrue 20 evaluable subjects over 20 months with 10 patients in each group. Subjects will be assigned to group 1 or group 2 according to the subject's disease stage.
The protocol will be conducted in two stages:
The 1st 3 patients will be enrolled to either group to receive DC vaccinations combined with standard chemotherapy. A safety analysis will be performed after the first 3 patients have completed 6 vaccines. If no vaccine dose-limiting toxicity occurs in any of the 3 patients then the study will proceed with stage 2. Stage 2 will include the enrollment of the remaining 17 patients.
- Conditions
- Pancreatic Cancer
- Being tested
- DC Vaccine + Standard of Care Chemotherapy
- Keywords
- Dendritic Cell Vaccine, FOLFIRINOX, nab-paclitaxel, gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC Vaccine + Standard of Care ChemotherapyBiological
4 doses of DC vaccine at 2 weeks interval, combined with either:
- Standard of care neoadjuvant folinic acid, oxaliplatin, irinotecan and 5- Fluorouracil (5FU) (FOLFIRINOX) regimen alone (6 cycles)
- FOLRIRINOX regimen followed by 5-FU chemoradiation or Gemcitabine Chemoradiation
- Gemcitabine + nab-paclitaxel
The first vaccination will include one intradermal injection of 100 μL at 15 x106 cells/mL in the upper thigh and one subcutaneous injection of 1 mL (15 x 106 cells/mL) .
The participants will receive 3 additional subcutaneous vaccinations, each injection of 1 mL at 15 x 106 cells/mL, at 2 weeks interval, on Day 2 of study weeks 3, 5 and 7.
Participants will receive 2 booster DC vaccinations subcutaneously of 1 mL at 15x106 cells/mL.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Group 1 will consist of patients with resectable, borderline resectable or locally advanced pancreatic cancer. Group 1 will receive DC Vaccine + Standard of Care Chemotherapy. Receives: Biological: DC Vaccine + Standard of Care Chemotherapy |
| Group 2 | Active comparator | Group 2 will consist of patients with metastatic pancreatic cancer, newly diagnosed/untreated metastatic pancreatic cancer, or metastatic pancreatic cancer who have undergone prior neo-adjuvant therapy. Group 2 will receive DC Vaccine + Standard of Care Chemotherapy. Receives: Biological: DC Vaccine + Standard of Care Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility of combining the DC vaccine with chemotherapy DC vaccine dose-limiting toxicities will be measured according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Follow up for toxicity will be recorded for the first 30 days following the last DC vaccination and any long-term toxicity will be followed for 3 years after completing study therapy.
Measured: 3 Years
Secondary outcomes (4)
Objective Response
Overall response rate will be assessed by using standard Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: 3 years
Overall Survival
Time from the start of therapy to death from any cause.
Measured: 3 years
Progression Free Survival
Time from enrollment until objective tumor progression or death
Measured: 3 Years
Average of all changes in Quality of Life (QoL) Score
Quality of Life score will be assessed by using self-administered questionnaires
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startAug 2015
- Primary completion24 Apr 2017
- Study completion24 Apr 2017
Why it stopped: The study was stopped because of loss of funding and no safety issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Becerra, MD, Principal investigator, Charles A. Sammons Cancer Center/Texas Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548169
- Sponsor's protocol ID
- 015-119
- Acronym
- PancVax
- Status last verified
- Jan 2019
- First submitted
- 10 Sep 2015
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Safety Trial of Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02548169
- Acronym / sponsor ID
- PancVax / 015-119
- Conditions
- Pancreatic Cancer
- Keywords
- Dendritic Cell Vaccine, FOLFIRINOX, nab-paclitaxel, gemcitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped because of loss of funding and no safety issues
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 24 Apr 2017 (actual)
- Study completion
- 24 Apr 2017 (actual)
- First posted
- 14 Sep 2015 (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 primary objective is to confirm clinical safety and feasibility of combining the antigen-loaded Dendritic Cell (DC) vaccine with chemotherapy including folinic acid, oxaliplatin, irinotecan and 5-Fluorouracil (5FU) (FOLFIRINOX) and nab-paclitaxel/gemcitabine in patients with pancreatic cancer.
The secondary objectives of this trial are to determine preliminary clinical efficacy based on response rates, overall survival and progression free survival compared with historic control, and surgical conversion rate as defined as percent of locally advanced (unresectable) patients achieving resectability within 6 months of treatment initiation. Also, to identify vaccine immunogenicity by measuring acquired, T cell-mediated immune activating events post-vaccination and to correlate clinical response with acquired immune responses.
Detailed description
This is a single center, exploratory pilot safety, open label, phase I trial that will evaluate the combination of DC vaccination in 2 groups of patients when combined with chemotherapy including FOLFIRINOX and gemcitabine+nab-paclitaxel in patients with pancreatic cancer. The investigations will accrue 20 evaluable subjects over 20 months with 10 patients in each group. Subjects will be assigned to group 1 or group 2 according to the subject's disease stage.
The protocol will be conducted in two stages:
The 1st 3 patients will be enrolled to either group to receive DC vaccinations combined with standard chemotherapy. A safety analysis will be performed after the first 3 patients have completed 6 vaccines. If no vaccine dose-limiting toxicity occurs in any of the 3 patients then the study will proceed with stage 2. Stage 2 will include the enrollment of the remaining 17 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: DC Vaccine + Standard of Care ChemotherapyGroup 1 will consist of patients with resectable, borderline resectable or locally advanced pancreatic cancer. Group 1 will receive DC Vaccine + Standard of Care Chemotherapy. |
| Group 2 | Active comparator | Biological: DC Vaccine + Standard of Care ChemotherapyGroup 2 will consist of patients with metastatic pancreatic cancer, newly diagnosed/untreated metastatic pancreatic cancer, or metastatic pancreatic cancer who have undergone prior neo-adjuvant therapy. Group 2 will receive DC Vaccine + Standard of Care Chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Suspected pancreatic ductal adenocarcinoma (PDAC) prior to diagnosis or histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology.
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.
- Serum Albumin greater than or equal to 2.0 gm/dL
- Expected survival greater than or equal to 6 months.
- Adequate hematologic function as defined by
Key exclusion criteria (16 listed)
- History of Organ transplant
- Other malignancy within 5 years, unless the probability of recurrence of the prior malignancy is <5% as determined by the principal investigator.
- Current, active immunosuppressive therapy such as cyclosporine, tacrolimus
- Subjects taking chronic systemic corticosteroid therapy for any reason are not eligible. Subjects may receive steroids as prophylactic anti-emetics, not toe exceed 10mg Decadron weekly. Subjects receiving inhaled or topical corticosteroids are eligible. Subjects who require chronic systemic corticosteroids after beginning vaccination will be removed from the study.
- Significant or uncontrolled congestive heart failure, myocardial infarction or significant ventricular arrhythmias within the last 6 months
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 |
|---|---|---|
| DC Vaccine + Standard of Care Chemotherapy4 doses of DC vaccine at 2 weeks interval, combined with either: * Standard of care neoadjuvant folinic acid, oxaliplatin, irinotecan and 5- Fluorouracil (5FU) (FOLFIRINOX) regimen alone (6 cycles) * FOLRIRINOX regimen followed by 5-FU chemoradiation or Gemcitabine Chemoradiation * Gemcitabine + nab-paclitaxel The first vaccination will include one intradermal injection of 100 μL at 15 x106 cells/mL in the upper thigh and one subcutaneous injection of 1 mL (15 x 106 cells/mL) . The participants will receive 3 additional subcutaneous vaccinations, each injection of 1 mL at 15 x 106 cells/mL, at 2 weeks interval, on Day 2 of study weeks 3, 5 and 7. Participants will receive 2 booster DC vaccinations subcutaneously of 1 mL at 15x106 cells/mL. | Biological | Group 1, Group 2 |
Primary outcome
Safety and feasibility of combining the DC vaccine with chemotherapy DC vaccine dose-limiting toxicities will be measured according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Time frame: 3 Years
Follow up for toxicity will be recorded for the first 30 days following the last DC vaccination and any long-term toxicity will be followed for 3 years after completing study therapy.
4 secondary outcomes
Objective Response
Time frame: 3 years
Overall Survival
Time frame: 3 years
Progression Free Survival
Time frame: 3 Years
Average of all changes in Quality of Life (QoL) Score
Time frame: 3 Years
Results and safety
The study was stopped early (reason given: The study was stopped because of loss of funding and no safety issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
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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.
Carlos Becerra, MD principal investigator
Charles A. Sammons Cancer Center/Texas Oncology
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 of Pancreatic Cancer, run by Baylor Research Institute 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 15 inclusion and 16 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: stopped early, as of the sponsor's last update on 29 Jan 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 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 was stopped early (reason given: The study was stopped because of loss of funding and no safety issues). Results are not available in the source record.
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?
Safety and feasibility of combining the DC vaccine with chemotherapy DC vaccine dose-limiting toxicities will be measured according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (time frame: 3 Years). 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 29 Jan 2019.