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A Single-Patient Study Using AGS 006

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ClinicalTrials.gov Identifier: NCT00664482
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : January 29, 2013
Sponsor:
Information provided by (Responsible Party):
Argos Therapeutics

Tracking Information
First Submitted Date  ICMJE April 21, 2008
First Posted Date  ICMJE April 23, 2008
Last Update Posted Date January 29, 2013
Study Start Date  ICMJE May 2007
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2008)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2008)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single-Patient Study Using AGS 006
Official Title  ICMJE A Single-Patient Study Using AGS 006 as an Immunotherapeutic in a Subject With Newly Diagnosed Resectable Pancreatic Cancer
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:

    1. Resection of pancreatic cancer,
    2. RNA acquisition from tumor specimen,
    3. RNA amplification,
    4. Infectious disease testing,
    5. Autoimmune disease testing,
    6. Two blood draws for immune response monitoring,
    7. Production leukapheresis, and
    8. Dendritic cell electroporation with RNA and immunotherapeutic production;
  • Events during Induction Period:

    1. Administer investigative treatment every 2 weeks for a total of five doses, followed by dosing every 4 weeks for a total of four doses,
    2. Two Induction Period blood draws (Week 6 and Week 12) for immune response monitoring, and
    3. One leukapheresis (Week 14) for immune response monitoring;
  • Events during Booster Period:

    1. Dose every 3 months until progression or 2 years after first AGS treatment,
    2. Potentially, one leukapheresis for immune response monitoring 12 months from the first dose, and
    3. One blood draw 2 weeks following dosing at Week 36 (1st booster dose) (approximately Week 38); and,
  • Events during study Close-Out:

    1. Close-Out upon progression or 28 days following immune response monitoring 2 years after first dose
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Biological: AGS-006
Autologous Therapy for Pancreatic Cancer
Study Arms  ICMJE Experimental: 1
AGS-006
Intervention: Biological: AGS-006
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2008)
1
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    1. Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.
    2. Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
    3. Voluntary informed consent given to participate in the study.

Exclusion Criteria:

  1. 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.
  2. Active autoimmune disease including, but not limited to:
  3. Active, acute, or chronic clinically significant infections including human immunodeficiency virus (HIV) and viral hepatitis.
  4. Known hypersensitivity to dimethyl sulfoxide (DMSO).
  5. Body weight less than 30 kg.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00664482
Other Study ID Numbers  ICMJE AGS-006-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Argos Therapeutics
Study Sponsor  ICMJE Argos Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sarah J Schlesinger, MD Rockefeller University
PRS Account Argos Therapeutics
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP