Resectable Pancreatic AdenocarcinomaPhase 1NCT00600002
Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma
A Phase 1 study testing GM-CSF in people with Resectable Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Edward Nelson at 1 site in United States.
Trial summary
The application of immunotherapeutic strategies that target the most potent antigen presenting cell, the dendritic cell (DC), are likely to substantially increase the magnitude of the anti-tumor immune response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Adenocarcinoma, Pancreatic Cancer
- What is being tested?
- GM-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Apr 2018
- 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
Who may be able to join
- Patients must have histological proven adenocarcinoma of the pancreas with potentially resectable disease based upon clinical staging.
- Expected survival must be greater than three (3) months.
- A Karnofsky Performance Status (KPS) must be 70 or greater.
- Patients must be >18 years of age. Because Leukine® is a "Pregnancy Category C" drug, female patients must be not be lactating and must be surgically sterile (via hysterectomy or bilateral tubal ligation), postmenopausal, or using acceptable methods of contraception if they are of child bearing potential. Female patients of childbearing potential must also have a negative serum pregnancy test.
- Patients must be able to understand and sign an informed consent form, which must comply with U.S. regulations (U.S. 21 Code of Federal Regulations (CFR) 50) and International Conference on Harmonisation (ICH) guidelines. Availability of alternative curative treatment must be fully explained to the patient and documented in the informed consent form.
- Eligible patients must meet the following laboratory parameters:
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- White blood cell (WBC) >3,000/mm3
- Platelets >100,000/mm3
- Hct >33% or Hgb >10.5 gm/dL
- Prothrombin time (PT) within 3 seconds of control
- Serum creatinine <1.5 mg/dL
- Serum calcium <11.0 mg/dL
- Serum Amylase < 2 times the upper limit of normal
- Negative HIV-Ag and HIV-Ab
Who cannot join
- Patients who have undergone previous treatment with a biological response modifier (interferons, interleukins) or prior immunotherapy within four (4) weeks of study enrollment.
- Patients currently requiring corticosteroids, under immune suppression for any reason including an organ allograft.
- Patients with known contraindications to analgesia or endoscopy.
- Patients with unstable cardiovascular disease (Class IV cardiovascular disease according to the New York Heart Association's functional criteria).
- Patients with any acute or chronic illness as judged clinically significant by the Investigators.
- Patients who have received prior chemotherapy or radiation therapy to the thorax within four (4) weeks of enrollment.
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- Prior surgery within 30 days of execution of the informed consent form.
- Persistent fever greater than 39 degrees Celsius unless clinical assessment attributes the etiology to be tumor.
- Primary malignancy (present or remote) of sites other than the pancreas, except for the basal cell epithelioma of the skin.
- Use of investigational drugs within 30 days of execution of the informed consent form.
- Clinically significant (symptomatic) third space fluid collection (i.e.: ascites, pleural effusion).
- Patients with a diagnosis of an autoimmune state, or any psychiatric illness that in the opinion of the Investigators would compromise treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chao Family Comprehensive Cancer Center
Orange, California, 92868
About this study
Official title: A Phase I Clinical Trial of GM-CSF Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma
The application of immunotherapeutic strategies that target the most potent antigen presenting cell, the dendritic cell (DC), are likely to substantially increase the magnitude of the anti-tumor immune response. Although there are issues of activation state and antigen load, mechanisms to increase the number of DCs available to the immune system are among the first steps in development of affective DC based immunotherapeutic strategies. The Central Hypothesis of our study is: Administration of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) to patients with pancreatic adenocarcinoma will result in enhance recruitment of DCs to the sentinel lymph node, into the peripheral blood, and/or tumor site. We propose performing a phase I, dose escalation, clinical trial of systemic and intra-tumoral GM-CSF administration for the treatment of pancreatic adenocarcinoma. This trial will be designed to assess toxicity and immunologic effects, principally dendritic cell recruitment. Patients with resectable pancreatic adenocarcinoma by clinical staging criteria will be eligible for enrollment.
The trial we propose is a phase I clinical trial of the addition of GM-CSF as a biological adjuvant to standard care for patients with potentially resectable pancreatic adenocarcinoma.
- Being tested
- GM-CSF
- Keywords
- GM-CSF, Leukine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSFBiological
Cohort 1: 50 ug/m2 given Intravenous. Cohort 2: 150 ug/m2 given Intravenous. Cohort 3: 250 ug/m2 given Intravenous. Cohort 4: 0 ug/m2 and vehicle (normal saline) given Intra-tumoral. Cohort 5: 50 ug/m2 given Intra-tumoral. Cohort 6: 150 ug/m2 given Intra-tumoral. Cohort 7: 250 ug/m2 given Intra-tumoral.
| Study group | Role | What they receive |
|---|---|---|
| GM-CSF | Experimental | Cohort 1: 50 ug/m2 given Intravenous. Cohort 2: 150 ug/m2 given Intravenous. Cohort 3: 250 ug/m2 given Intravenous. Cohort 4: 0 ug/m2 and vehicle (normal saline) given Intra-tumoral. Cohort 5: 50 ug/m2 given Intra-tumoral. Cohort 6: 150 ug/m2 given Intra-tumoral. Cohort 7: 250 ug/m2 given Intra-tumoral. Receives: Biological: GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate toxicity, dendritic cell recruitment, and immune parameters
Measured: 2 years
Secondary outcomes (5)
Evaluate patient survival
Measured: 2 years
Evaluate progression free survival
Measured: 2 years
Evaluate time to treatment failure
Measured: 2 years
Evaluate quality of life
Measured: 2 years
Evaluate biochemical markers
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startJun 2004
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic AdenocarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Nelson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edward Nelson, University of California, Irvine
- Investigators
- Edward L Nelson, M.D., Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600002
- Sponsor's protocol ID
- UCI 02-69
- Other IDs
- 2003-2972
- Status last verified
- Jun 2018
- First submitted
- 17 Jan 2008
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of GM-CSF Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00600002
- Acronym / sponsor ID
- UCI 02-69
- Keywords
- GM-CSF, Leukine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Edward NelsonUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 24 Jan 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.
The application of immunotherapeutic strategies that target the most potent antigen presenting cell, the dendritic cell (DC), are likely to substantially increase the magnitude of the anti-tumor immune response. Although there are issues of activation state and antigen load, mechanisms to increase the number of DCs available to the immune system are among the first steps in development of affective DC based immunotherapeutic strategies. The Central Hypothesis of our study is: Administration of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) to patients with pancreatic adenocarcinoma will result in enhance recruitment of DCs to the sentinel lymph node, into the peripheral blood, and/or tumor site. We propose performing a phase I, dose escalation, clinical trial of systemic and intra-tumoral GM-CSF administration for the treatment of pancreatic adenocarcinoma. This trial will be designed to assess toxicity and immunologic effects, principally dendritic cell recruitment. Patients with resectable pancreatic adenocarcinoma by clinical staging criteria will be eligible for enrollment.
The trial we propose is a phase I clinical trial of the addition of GM-CSF as a biological adjuvant to standard care for patients with potentially resectable pancreatic adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GM-CSF | Experimental | Biological: GM-CSFCohort 1: 50 ug/m2 given Intravenous. Cohort 2: 150 ug/m2 given Intravenous. Cohort 3: 250 ug/m2 given Intravenous. Cohort 4: 0 ug/m2 and vehicle (normal saline) given Intra-tumoral. Cohort 5: 50 ug/m2 given Intra-tumoral. Cohort 6: 150 ug/m2 given Intra-tumoral. Cohort 7: 250 ug/m2 given Intra-tumoral. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have histological proven adenocarcinoma of the pancreas with potentially resectable disease based upon clinical staging.
- Expected survival must be greater than three (3) months.
- A Karnofsky Performance Status (KPS) must be 70 or greater.
- Patients must be >18 years of age. Because Leukine® is a "Pregnancy Category C" drug, female patients must be not be lactating and must be surgically sterile (via hysterectomy or bilateral tubal ligation), postmenopausal, or using acceptable methods of contraception if they are of child bearing potential. Female patients of childbearing potential must also have a negative serum pregnancy test.
- Patients must be able to understand and sign an informed consent form, which must comply with U.S. regulations (U.S. 21 Code of Federal Regulations (CFR) 50) and International Conference on Harmonisation (ICH) guidelines. Availability of alternative curative treatment must be fully explained to the patient and documented in the informed consent form.
Key exclusion criteria (12 listed)
- Patients who have undergone previous treatment with a biological response modifier (interferons, interleukins) or prior immunotherapy within four (4) weeks of study enrollment.
- Patients currently requiring corticosteroids, under immune suppression for any reason including an organ allograft.
- Patients with known contraindications to analgesia or endoscopy.
- Patients with unstable cardiovascular disease (Class IV cardiovascular disease according to the New York Heart Association's functional criteria).
- Patients with any acute or chronic illness as judged clinically significant by the Investigators.
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 |
|---|---|---|
| GM-CSFCohort 1: 50 ug/m2 given Intravenous. Cohort 2: 150 ug/m2 given Intravenous. Cohort 3: 250 ug/m2 given Intravenous. Cohort 4: 0 ug/m2 and vehicle (normal saline) given Intra-tumoral. Cohort 5: 50 ug/m2 given Intra-tumoral. Cohort 6: 150 ug/m2 given Intra-tumoral. Cohort 7: 250 ug/m2 given Intra-tumoral. | Biological | GM-CSF |
Primary outcome
Evaluate toxicity, dendritic cell recruitment, and immune parameters
Time frame: 2 years
5 secondary outcomes
Evaluate patient survival
Time frame: 2 years
Evaluate progression free survival
Time frame: 2 years
Evaluate time to treatment failure
Time frame: 2 years
Evaluate quality of life
Time frame: 2 years
Evaluate biochemical markers
Time frame: 2 years
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 11 Jun 2018.
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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.
Edward L Nelson, M.D. principal investigator
Chao Family 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 GM-CSF in people with Resectable Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Edward Nelson 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 14 inclusion and 12 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 11 Jun 2018. 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?
Evaluate toxicity, dendritic cell recruitment, and immune parameters (time frame: 2 years). 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 11 Jun 2018.