A Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Pancreatic Adenocarcinoma

Pancreatic Adenocarcinoma Non-resectable Clinical Trial

Official title:

A Feasibility and Safety Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677962
• Other study ID #: 101778
• Status: Completed
• Phase: Phase 1
• First received: August 17, 2012
• Last updated: December 13, 2016
• Start date: August 2012
• Est. completion date: May 2016

Study information

• Verified date: December 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

• 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

Exclusion Criteria:

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.

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma Non-resectable
• Pancreatic Neoplasms

Intervention

Biological:
• Poly-ICLC

• dendritic cell

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from study consent to last treatment (Day 56)	Yes
Primary	Primary Objective	Determining the feasibility of generating dendritic cells and administering these cells as a vaccine to patients	from study consent to last treatment (Day 56)	Yes
Secondary	Secondary Outcome	Number of Participants With Tumor Response	Average three months Per Participant	No
Secondary	Secondary Objective	Measure overall Survival	Post treatment	No