Pancreatic CancerPhase 1NCT00547144
Phase I/II Intratumoral DC Immunotherapy With Gemcitabine & XRT in Unresectable Pancreatic Cancer
A Phase 1 study testing Gemcitabine and Dendritic Cell Immunotherapy in people with Pancreatic Cancer, run by George Albert Fisher at 1 site in United States.
Trial summary
To determine the safety, feasibility and appropriate dendritic cell dose to vaccinate patients with pancreas cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine and Dendritic Cell Immunotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Apr 2008
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:1. Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas. The site of the primary lesion should be confirmed endoscopically, radiologically, or surgically to be in the pancreas.
- Patients must be deemed unresectable due to involvement of critical vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable.
- Patients must have a primary or metastatic lesion measurable in at least one dimension by RECIST criteria within 4 weeks prior to entry of study 4. More than 4 weeks must have elapsed from the time of major surgery or completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects.
- Life expectancy of >3 months. 6. Karnofsky performance status >70%. 7. Patients must have normal organ and marrow functions as defined below: absolute neutrophil count >1,500/mm3 platelets >70,000/mm3 total bilirubin <1.5 mg/dL AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance >60mL/min/1.73 m2 for patients with creatinine levels above institutional normal. albumin > 2.8 mg/dL 8. Patients must have adequate clotting function (platelet > 70k; INR<1.4; PTT<60).
- Age >18 years. 10. The effects of DCs on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- No history of autoimmune diseases. 12. Ability to understand the study protocol and a willingness to sign a written informed consent document. Exclusion Criteria:1. Patients receiving anticoagulation therapy.
- Patients who have received prior gemcitabine or radiation therapy to the pancreatic bed 3. Patients receiving any other investigational agents. 4. Patients with known brain metastases will be excluded because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse effects.
- Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
- Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase I/II Trial of Intratumoral Dendritic Cell Immunotherapy in Combination With Gemcitabine and Stereotactic Radiosurgery in Unresectable Pancreatic Cancer
To determine the safety, feasibility and appropriate dendritic cell dose to vaccinate patients with pancreas cancer
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, Dendritic Cell Immunotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
1000 mg/m2 intravenoulsy once a week according to protocol schedule
Dendritic Cell ImmunotherapyProcedure or surgery
Also called DC Therapy, Dendritic Cell Therapy
The cells will be administered by intratumoral injection on 2 different days(at least 21 days apart)
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine | Experimental | Not described Receives: Drug: Gemcitabine; Procedure: Dendritic Cell Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
o evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells.
Phase II: To determine the overall response rate for this regimen as determined by radiographic criteria.
Phase I: To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with gemcitabine and stereotactic radiosurgery
To determine the time to tumor progression for this regimen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startOct 2005
- Primary completionApr 2008
- Study completionApr 2008
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Albert Fisher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, George Albert Fisher, Stanford University
- Investigators
- Edgar G Engleman, Principal investigator, Stanford UniversityGeorge Albert Fisher M.D. Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547144
- Sponsor's protocol ID
- PANC0003
- Other IDs
- 95935, 1454
- Status last verified
- Aug 2012
- First submitted
- 18 Oct 2007
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Intratumoral Dendritic Cell Immunotherapy in Combination With Gemcitabine and Stereotactic Radiosurgery in Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00547144
- Acronym / sponsor ID
- PANC0003
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- George Albert FisherUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 22 Oct 2007 (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.
To determine the safety, feasibility and appropriate dendritic cell dose to vaccinate patients with pancreas cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine | Experimental | Drug: Gemcitabine, Procedure: Dendritic Cell Immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| GemcitabineAlso: Gemzar1000 mg/m2 intravenoulsy once a week according to protocol schedule | Drug | Gemcitabine |
| Dendritic Cell ImmunotherapyAlso: DC Therapy, Dendritic Cell TherapyThe cells will be administered by intratumoral injection on 2 different days(at least 21 days apart) | Procedure or surgery | Gemcitabine |
Primary outcome
o evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells.
Phase II: To determine the overall response rate for this regimen as determined by radiographic criteria.
Phase I: To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with gemcitabine and stereotactic radiosurgery
To determine the time to tumor progression for this regimen.
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 8 Nov 2012.
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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.
Edgar G Engleman principal investigator
Stanford University
George Albert Fisher M.D. Ph.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine and Dendritic Cell Immunotherapy in people with Pancreatic Cancer, run by George Albert Fisher 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?
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 8 Nov 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
o evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells.. The study lists 4 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 8 Nov 2012; AzTrials last refreshed its copy on 7 Nov 2026.