Pancreatic CancerNCT00664482
A Single-Patient Study Using AGS 006
A study testing AGS-006 in people with Pancreatic Cancer, run by Argos Therapeutics at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- AGS-006
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Single-patient, open-label clinical study:
- Events during Pre-Treatment Period:
- Resection of pancreatic cancer,
- RNA acquisition from tumor specimen,
- RNA amplification,
- Infectious disease testing,
- Autoimmune disease testing,
- Two blood draws for immune response monitoring,
- Production leukapheresis, and
- Dendritic cell electroporation with RNA and immunotherapeutic production;
- Events during Induction Period:
- Administer investigative treatment every 2 weeks for a total of five doses, followed by dosing every 4 weeks for a total of four doses,
- Two Induction Period blood draws (Week 6 and Week 12) for immune response monitoring, and
- One leukapheresis (Week 14) for immune response monitoring;
- Events during Booster Period:
- Dose every 3 months until progression or 2 years after first AGS treatment,
- Potentially, one leukapheresis for immune response monitoring 12 months from the first dose, and
- One blood draw 2 weeks following dosing at Week 36 (1st booster dose) (approximately Week 38); and,
- Events during study Close-Out:
- Close-Out upon progression or 28 days following immune response monitoring 2 years after first dose
- Conditions
- Pancreatic Cancer
- Being tested
- AGS-006
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGS-006Biological
Autologous Therapy for Pancreatic Cancer
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AGS-006 Receives: Biological: AGS-006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startMay 2007
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Argos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah J Schlesinger, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664482
- Sponsor's protocol ID
- AGS-006-001
- Status last verified
- Jan 2013
- First submitted
- 21 Apr 2008
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Patient Study Using AGS 006 as an Immunotherapeutic in a Subject With Newly Diagnosed Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00664482
- Acronym / sponsor ID
- AGS-006-001
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Argos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Single-patient, open-label clinical study:
- Events during Pre-Treatment Period:
- Resection of pancreatic cancer,
- RNA acquisition from tumor specimen,
- RNA amplification,
- Infectious disease testing,
- Autoimmune disease testing,
- Two blood draws for immune response monitoring,
- Production leukapheresis, and
- Dendritic cell electroporation with RNA and immunotherapeutic production;
- Events during Induction Period:
- Administer investigative treatment every 2 weeks for a total of five doses, followed by dosing every 4 weeks for a total of four doses,
- Two Induction Period blood draws (Week 6 and Week 12) for immune response monitoring, and
- One leukapheresis (Week 14) for immune response monitoring;
- Events during Booster Period:
- Dose every 3 months until progression or 2 years after first AGS treatment,
- Potentially, one leukapheresis for immune response monitoring 12 months from the first dose, and
- One blood draw 2 weeks following dosing at Week 36 (1st booster dose) (approximately Week 38); and,
- Events during study Close-Out:
- Close-Out upon progression or 28 days following immune response monitoring 2 years after first dose
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: AGS-006AGS-006 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGS-006Autologous Therapy for Pancreatic Cancer | Biological | 1 |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah J Schlesinger, MD principal investigator
Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AGS-006 in people with Pancreatic Cancer, run by Argos Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2013.