Back to resultsA Single-Patient Study Using AGS 006
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AGS-006
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
A male subject 18 years of age or older with newly diagnosed resectable pancreatic cancer who, in the opinion of the investigator, is suitable for participation in the study will be eligible for inclusion if all of the following criteria apply:
- Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.
- Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
- Voluntary informed consent given to participate in the study.
Exclusion Criteria:
- Any serious medical condition such as cardiopulmonary disease, circulatory compromise, hepatic or renal dysfunction, or other illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.
- Active autoimmune disease including, but not limited to:
- Active, acute, or chronic clinically significant infections including human immunodeficiency virus (HIV) and viral hepatitis.
- Known hypersensitivity to dimethyl sulfoxide (DMSO).
- Body weight less than 30 kg.
Sites / Locations
- Rockefeller University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
AGS-006
Outcomes
Primary Outcome Measures
Treatment-emergent changes in vital signs (blood pressure, heart rate, respiratory rate, and body temperature) from baseline values obtained prior to each investigative treatment
Incidence of treatment-emergent adverse events graded according to the Common Terminology Criteria for Adverse Events
Treatment-emergent adenopathy, tenderness, or inflammation (inguinal and axillary) assessed before and after each dose
Treatment-emergent changes in autoimmunity evaluations as measured by clinical signs and symptoms and laboratory assessments at periodic intervals during the Treatment Period.
Treatment-emergent changes in localized injection site reactions following each dose
Secondary Outcome Measures
Assessment of progression-free survival (PFS) estimated from the date of subject registration - Standard Response Evaluation Criteria in Solid Tumors (RECIST) definitions of progressive disease (PD) will contribute to estimating the interval for PFS.
T cell response to RNA-electroporated DCs will be assessed by flow cytometry using blood cells collected according to protocol time and events
Positive immune response
Feasibility
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00664482
Brief Title
A Single-Patient Study Using AGS 006
Official Title
A Single-Patient Study Using AGS 006 as an Immunotherapeutic in a Subject With Newly Diagnosed Resectable Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Argos Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Argos Therapeutics, Inc., (Argos) proposes to study AGS-006 in a subject with newly diagnosed resectable pancreatic cancer. The AGS 006 immunotherapeutic may potentially offer a desired additional option to conventional treatments for pancreatic carcinoma.
Detailed Description
Single-patient, open-label clinical study:
Events during Pre-Treatment Period:
Resection of pancreatic cancer,
RNA acquisition from tumor specimen,
RNA amplification,
Infectious disease testing,
Autoimmune disease testing,
Two blood draws for immune response monitoring,
Production leukapheresis, and
Dendritic cell electroporation with RNA and immunotherapeutic production;
Events during Induction Period:
Administer investigative treatment every 2 weeks for a total of five doses, followed by dosing every 4 weeks for a total of four doses,
Two Induction Period blood draws (Week 6 and Week 12) for immune response monitoring, and
One leukapheresis (Week 14) for immune response monitoring;
Events during Booster Period:
Dose every 3 months until progression or 2 years after first AGS treatment,
Potentially, one leukapheresis for immune response monitoring 12 months from the first dose, and
One blood draw 2 weeks following dosing at Week 36 (1st booster dose) (approximately Week 38); and,
Events during study Close-Out:
Close-Out upon progression or 28 days following immune response monitoring 2 years after first dose
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AGS-006
Intervention Type
Biological
Intervention Name(s)
AGS-006
Intervention Description
Autologous Therapy for Pancreatic Cancer
Primary Outcome Measure Information:
Title
Treatment-emergent changes in vital signs (blood pressure, heart rate, respiratory rate, and body temperature) from baseline values obtained prior to each investigative treatment
Title
Incidence of treatment-emergent adverse events graded according to the Common Terminology Criteria for Adverse Events
Title
Treatment-emergent adenopathy, tenderness, or inflammation (inguinal and axillary) assessed before and after each dose
Title
Treatment-emergent changes in autoimmunity evaluations as measured by clinical signs and symptoms and laboratory assessments at periodic intervals during the Treatment Period.
Title
Treatment-emergent changes in localized injection site reactions following each dose
Secondary Outcome Measure Information:
Title
Assessment of progression-free survival (PFS) estimated from the date of subject registration - Standard Response Evaluation Criteria in Solid Tumors (RECIST) definitions of progressive disease (PD) will contribute to estimating the interval for PFS.
Title
T cell response to RNA-electroporated DCs will be assessed by flow cytometry using blood cells collected according to protocol time and events
Title
Positive immune response
Title
Feasibility
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A male subject 18 years of age or older with newly diagnosed resectable pancreatic cancer who, in the opinion of the investigator, is suitable for participation in the study will be eligible for inclusion if all of the following criteria apply:
Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.
Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
Voluntary informed consent given to participate in the study.
Exclusion Criteria:
Any serious medical condition such as cardiopulmonary disease, circulatory compromise, hepatic or renal dysfunction, or other illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.
Active autoimmune disease including, but not limited to:
Active, acute, or chronic clinically significant infections including human immunodeficiency virus (HIV) and viral hepatitis.
Known hypersensitivity to dimethyl sulfoxide (DMSO).
Body weight less than 30 kg.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah J Schlesinger, MD
Organizational Affiliation
Rockefeller University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rockefeller University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
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A Single-Patient Study Using AGS 006
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