Dendritic Cell Vaccine and Chemotherapy for Patients With... | NCT02548169

NCT02548169

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Biological: DC Vaccine + Standard of Care Chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DC Vaccine + Standard of Care Chemotherapy	Biological	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	3 Years

Secondary Outcomes

Measure	Description	Time Frame
Objective Response	Overall response rate will be assessed by using standard Response Evaluation Criteria in Solid Tumors (RECIST).	3 years
Overall Survival	Time from the start of therapy to death from any cause.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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.

Exclusion Criteria:

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
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

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms