2007-05
2011-10
2011-10
1
NCT00664482
Argos Therapeutics
Argos Therapeutics
INTERVENTIONAL
A Single-Patient Study Using AGS 006
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.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2008-04-21 | N/A | 2013-01-22 |
2008-04-22 | N/A | 2013-01-29 |
2008-04-23 | N/A | 2013-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 1 AGS-006 | BIOLOGICAL: AGS-006
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | Measure Description | Time Frame |
|---|---|---|
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
MALE
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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