A Single-Patient Study Using AGS 006

A Single-Patient Study Using AGS 006 as an Immunotherapeutic in a Subject With Newly Diagnosed Resectable Pancreatic Cancer

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Biological: AGS-006

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: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Rockefeller University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; AGS-006	Biological: AGS-006; Autologous Therapy for Pancreatic Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Feasibility
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

Collaborators and Investigators

• Sponsor: Argos Therapeutics
• Investigators: Principal Investigator: Sarah J Schlesinger, MD, Rockefeller University

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: April 21, 2008
• First Submitted That Met QC Criteria: April 22, 2008
• First Posted (Estimate): April 23, 2008

Study Record Updates

• Last Update Posted (Estimate): January 29, 2013
• Last Update Submitted That Met QC Criteria: January 22, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: AGS-006-001