Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer

NCT02548169 | Terminated Phase 1 DMC

• 1 other identifier: 015-119
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pancreatic Cancer

Keywords

Dendritic Cell Vaccine; FOLFIRINOX; nab-paclitaxel; gemcitabine

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Objective Response

  3 years

• Overall Survival

  3 years

• Progression Free Survival

  3 Years

• Average of all changes in Quality of Life (QoL) Score

  3 Years

Study Arms (2)

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

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.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Carlos Becerra, MD

  Charles A. Sammons Cancer Center/Texas Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 14, 2015
• Study Start: August 1, 2015
• Primary Completion: April 24, 2017
• Study Completion: April 24, 2017
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

US (1)