A Single-Patient Study Using AGS 006

NCT00664482 | Completed

• 1 other identifier: AGS-006-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

Study Arms (1)

1

EXPERIMENTAL

AGS-006

Biological: AGS-006

Interventions

AGS-006 BIOLOGICAL

Autologous Therapy for Pancreatic Cancer

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Argos Therapeutics: lead

Study Sites (1)

Rockefeller University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Sarah J Schlesinger, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 23, 2008
• Study Start: May 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

US (1)