A Single-Patient Study Using AGS 006

Pancreatic Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT00664482
• Study type: Interventional
• Source: Argos Therapeutics
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Completion date: October 2011