Metastatic Pancreatic CarcinomaPhase 1NCT00843830
A Pilot Study Assessing Intra-Metastasis Administration of Autologous KLH-pulsed Dendritic Cells With Tumoral Radiation Therapy in Patients With Metastatic Pancreatic Carcinoma
A Phase 1 study testing tumoral irradiation and Dendritic cell vaccination in people with Metastatic Pancreatic Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This study is being done to determine whether it is possible to use an investigational vaccine that consists of dendritic cells in patients with pancreas cancer. Dendritic cells are immune cells that are obtained from your blood that are important in the body's immune response to foreign substances. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Carcinoma
- What is being tested?
- tumoral irradiation and Dendritic cell vaccination
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Apr 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Pathologic diagnosis of pancreatic carcinoma
- Radiologic evidence of hepatic metastasis with at least one lesion > 2.0 cm that is amenable to ultrasound or CT guided intra-tumoral DC injection
- Age > 18
- Life expectancy > 3 months
- Karnofsky Performance Status > 70%
- Patients must not have received any anti-neoplastic chemotherapy, immunotherapy or radiotherapy for the four weeks preceding entry onto the study (six weeks for nitrosoureas and mitomycin C).
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- Adequate baseline hematopoietic function defined as WBC (white blood cell) > 3000/mm3, hemoglobin > 9g/dl, and platelet count > 100,000/mm3.
- Adequate baseline organ function defined as creatinine < 2.0, total bilirubin < 2.0 mg/dl
- Patients taking warfarin are not eligible. Adequate coagulation function defined as PT (prothrombin time) < 15, INR < 1.5 and PTT (partial thromboplastin time) < 35.
- Ability to give informed consent
Who cannot join
- Previous anti-tumor vaccine therapy
- Prior hepatic irradiation
- Known brain metastases
- History of prior autoimmune diseases (e.g. SLE (systemic lupus erythematosus), rheumatoid arthritis, myasthenia gravis)
- Regular corticosteroid use within the past one year or any corticosteroid use in the four weeks preceding study entry
- Evidence of HIV infection, AIDS, Hepatitis B or Hepatitis C infection
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- Active bacterial, fungal or viral infection
- Pregnancy or lactation; women of childbearing potential and men must agree to use effective contraception during the course of this clinical trial
- Uncontrolled or unstable medical conditions including angina, arrhythmias, bleeding, or thromboembolic conditions,
- Any medical or psychiatric illness that might compromise the patients ability to tolerate treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Universtiy of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
This study is being done to determine whether it is possible to use an investigational vaccine that consists of dendritic cells in patients with pancreas cancer. Dendritic cells are immune cells that are obtained from your blood that are important in the body's immune response to foreign substances. The vaccine would be injected directly into a tumor that has spread to the liver after a short course of radiation therapy has been given to that tumor. The study will try to determine if this treatment would be safe and effective in treating this cancer.
This is a phase 1 pilot study of this treatment. Phase 1 trials test the best way to give a treatment where little is known about its possible risks or benefits. Phase 2 studies then test the possible benefits of a treatment and may show the specific situations where they are seen. Promising treatments are then tested in Phase 3 trials which compare the new treatment to standard treatment in a larger group of patients. Phase 4 trials are those conducted on a treatment after it has been approved for general use outside of research. A pilot study tests a treatment in a small number of patients to learn if and how the treatment could be tested in a larger group. Pilot studies can be performed at any phase but are commonly performed in the earliest phases of research on a treatment.
- Conditions
- Metastatic Pancreatic Carcinoma
- Being tested
- tumoral irradiation, Dendritic cell vaccination
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumoral irradiationRadiation
On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
Dendritic cell vaccinationBiological
Three intra-tumoral injections of 1 ml cell suspensions of KLH (keyhole limpet hemocyanin)- pulsed DC (dendritic cells) will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants will receive tumoral irradiation and dendritic cell vaccination. Receives: Radiation: tumoral irradiation; Biological: Dendritic cell vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination.
The primary objective of this study was to evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. The treatment will be deemed feasible if 80% or more patients complete radiation therapy, all three vaccinations, and evaluation for tumor response four weeks after the third vaccination.
Measured: 10 weeks
Secondary outcomes (1)
Number of Patients That Respond to Treatment
To evaluate the anti-tumor response as determined by RECIST criteria
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startOct 2006
- Primary completionDec 2008
- Study completionApr 2010
Why it stopped: Study closed early secondary to inability to obtain grant funding to conduct.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Pancreatic CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark M. Zalupski, M.D., Principal investigator, Universtiy of Michigan Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843830
- Sponsor's protocol ID
- UMCC 2005.135
- Status last verified
- Nov 2015
- First submitted
- 12 Feb 2009
- Last updated
- 8 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing Intra-Metastasis Administration of Autologous KLH-pulsed Dendritic Cells With Tumoral Radiation Therapy in Patients With Metastatic Pancreatic Carcinoma
- ClinicalTrials.gov ID
- NCT00843830
- Acronym / sponsor ID
- UMCC 2005.135
- Conditions
- Metastatic Pancreatic Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed early secondary to inability to obtain grant funding to conduct.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Feb 2009 (estimated)
- Results
- Posted 5 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to determine whether it is possible to use an investigational vaccine that consists of dendritic cells in patients with pancreas cancer. Dendritic cells are immune cells that are obtained from your blood that are important in the body's immune response to foreign substances. The vaccine would be injected directly into a tumor that has spread to the liver after a short course of radiation therapy has been given to that tumor. The study will try to determine if this treatment would be safe and effective in treating this cancer.
This is a phase 1 pilot study of this treatment. Phase 1 trials test the best way to give a treatment where little is known about its possible risks or benefits. Phase 2 studies then test the possible benefits of a treatment and may show the specific situations where they are seen. Promising treatments are then tested in Phase 3 trials which compare the new treatment to standard treatment in a larger group of patients. Phase 4 trials are those conducted on a treatment after it has been approved for general use outside of research. A pilot study tests a treatment in a small number of patients to learn if and how the treatment could be tested in a larger group. Pilot studies can be performed at any phase but are commonly performed in the earliest phases of research on a treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Radiation: tumoral irradiation, Biological: Dendritic cell vaccinationParticipants will receive tumoral irradiation and dendritic cell vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologic diagnosis of pancreatic carcinoma
- Radiologic evidence of hepatic metastasis with at least one lesion > 2.0 cm that is amenable to ultrasound or CT guided intra-tumoral DC injection
- Age > 18
- Life expectancy > 3 months
- Karnofsky Performance Status > 70%
Key exclusion criteria (10 listed)
- Previous anti-tumor vaccine therapy
- Prior hepatic irradiation
- Known brain metastases
- History of prior autoimmune diseases (e.g. SLE (systemic lupus erythematosus), rheumatoid arthritis, myasthenia gravis)
- Regular corticosteroid use within the past one year or any corticosteroid use in the four weeks preceding study entry
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 |
|---|---|---|
| tumoral irradiationOn day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4) | Radiation | Treatment Arm |
| Dendritic cell vaccinationThree intra-tumoral injections of 1 ml cell suspensions of KLH (keyhole limpet hemocyanin)- pulsed DC (dendritic cells) will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting. | Biological | Treatment Arm |
Primary outcome
The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination.
Time frame: 10 weeks
The primary objective of this study was to evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. The treatment will be deemed feasible if 80% or more patients complete radiation therapy, all three vaccinations, and evaluation for tumor response four weeks after the third vaccination.
1 secondary outcome
Number of Patients That Respond to Treatment
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mark M. Zalupski, M.D. principal investigator
Universtiy of Michigan Comprehensive Cancer Center
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 tumoral irradiation and Dendritic cell vaccination in people with Metastatic Pancreatic Carcinoma, run by University of Michigan Rogel Cancer Center 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 10 inclusion and 10 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: stopped early, as of the sponsor's last update on 8 Dec 2015. 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?
Yes. Results are posted in the registry (first posted 5 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination. (time frame: 10 weeks). 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 Dec 2015.