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A Single-Patient Study Using AGS 006

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00664482
First Posted: April 23, 2008
Last Update Posted: January 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Argos Therapeutics
  Purpose
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.

Condition Intervention
Pancreatic Cancer Biological: AGS-006

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Patient Study Using AGS 006 as an Immunotherapeutic in a Subject With Newly Diagnosed Resectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Argos Therapeutics:

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

Enrollment: 1
Study Start Date: May 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AGS-006
Biological: AGS-006
Autologous Therapy for Pancreatic Cancer

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

    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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664482


Locations
United States, New York
Rockefeller University
New York, New York, United States, 10021
Sponsors and Collaborators
Argos Therapeutics
Investigators
Principal Investigator: Sarah J Schlesinger, MD Rockefeller University
  More Information

Responsible Party: Argos Therapeutics
ClinicalTrials.gov Identifier: NCT00664482     History of Changes
Other Study ID Numbers: AGS-006-001
First Submitted: April 21, 2008
First Posted: April 23, 2008
Last Update Posted: January 29, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases