A Single-Patient Study Using AGS 006

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Argos Therapeutics
ClinicalTrials.gov Identifier:
NCT00664482
First received: April 21, 2008
Last updated: January 22, 2013
Last verified: January 2013
  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: 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 [ Designated as safety issue: Yes ]
  • Incidence of treatment-emergent adverse events graded according to the Common Terminology Criteria for Adverse Events [ Designated as safety issue: Yes ]
  • Treatment-emergent adenopathy, tenderness, or inflammation (inguinal and axillary) assessed before and after each dose [ Designated as safety issue: Yes ]
  • Treatment-emergent changes in autoimmunity evaluations as measured by clinical signs and symptoms and laboratory assessments at periodic intervals during the Treatment Period. [ Designated as safety issue: Yes ]
  • Treatment-emergent changes in localized injection site reactions following each dose [ Designated as safety issue: Yes ]

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. [ Designated as safety issue: No ]
  • T cell response to RNA-electroporated DCs will be assessed by flow cytometry using blood cells collected according to protocol time and events [ Designated as safety issue: No ]
  • Positive immune response [ Designated as safety issue: No ]
  • Feasibility [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Argos Therapeutics
ClinicalTrials.gov Identifier: NCT00664482     History of Changes
Other Study ID Numbers: AGS-006-001
Study First Received: April 21, 2008
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 24, 2014