Pancreatic CancerPhase 1/2NCT00795977
Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer
A Phase 1/2 study testing dendritic cells, OK-432 in people with Pancreatic Cancer, run by Fukushima Medical University at 1 site in Japan.
Trial summary
The purpose of this study is to confirm safety and immunological responses of Preoperative intratumor dendritic cells injection immunotherapy using immature dendritic cells with S pyogenes Preparation (OK-432) for patients with resectable pancreatic cancer for pancreatic cancer patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- dendritic cells, OK-432
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2003to Nov 2012
- Phase
- Phase 1/2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resectable pancreatic cancer without distant metastasis:
- ECOG performance status 0-2
- Laboratory values as follows 3,500/mm3 <WBC<12000/mm3 Platelet count>100,000/mm3 T-Bil<2.0mg/dl BUN<25mg/dl, Creatinin<1.5mg/dl, 24h Ccr>50ml/min Normal ECG
- Able and willing to give valid written informed consent
Who cannot join
- Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- Breast-feeder
- Active or uncontrolled infection
- Active or uncontrolled other malignancy
- Steroids or immunosuppressing agent dependant status
- Interstitial pneumonia
- Decision of unsuitableness by principal investigator or physician-in-charge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study on Intratumor Dendritic Cell Injection Immunotherapy Using Immature Dendritic Cells With S Pyogenes Preparation (OK-432) for Patients With Resectable Pancreatic Cancer
The purpose of this study is to confirm safety and immunological responses of Preoperative intratumor dendritic cells injection immunotherapy using immature dendritic cells with S pyogenes Preparation (OK-432) for patients with resectable pancreatic cancer for pancreatic cancer patients.
Read the detailed description
The prognosis of pancreatic cancer is extremely poor even with extensive surgery, and development of new treatment modalities is much-expected for cure of this disease. Dendritic cells (DCs) immunotherapy is expected favorable outcome when it is approached directly to the cancer tissue. To evaluate safety and immunological responses, we conducted a phase I/II study of intra-tumor DCs immunotherapy for pancreatic cancer patients.
- Conditions
- Pancreatic Cancer
- Being tested
- dendritic cells, OK-432
- Keywords
- preoperative, intratumor, dendritic cells, pancreatic cancer, OK-432
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dendritic cells, OK-432Biological
Single Group Assignment
| Study group | Role | What they receive |
|---|---|---|
| dendritic cells | Experimental | Not described Receives: Biological: dendritic cells, OK-432 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with OK-432
Measured: 2 years
Secondary outcomes (2)
To determine the overall response rate for this regimen as determined by overall and disease-free survival.
Measured: 2 years
To evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells
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 posted21 Nov 2008 (estimated)
- Study startNov 2003
- Primary completionNov 2011 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fukushima Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akira Kenjo, Fukushima Medical University
- Investigators
- Mitsukazu Gotoh, MD & PhD, Study chair, Fukushima Medical University, Department of Surgery 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795977
- Sponsor's protocol ID
- 198
- Status last verified
- Sep 2011
- First submitted
- 19 Nov 2008
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kanzaki N, Terashima M, Kashimura S, Hoshino M, Ohtani S, Matsuyama S, Hoshino Y, Kogure M, Oshibe I, Endo H, Saito T, Yaginuma H, Gotoh M, Ohto H. Understanding the response of dendritic cells to activation by streptococcal preparation OK-432. Anticancer Res. 2005 Nov-Dec;25(6B):4231-8.
PubMed 16309221Takekuni K, Sakon M, Kishimoto S, Amano M, Sekimoto M, Aoki T, Oosato H, Dohno K, Umeshita K, Gotoh M, Monden T, Monden M. [A patient with unresectable cancer of pancreas head, effectively treated by a local injection of the mixture of OK-432, fibrinogen and thrombin]. Gan To Kagaku Ryoho. 1996 Sep;23(11):1621-3. Japanese.
PubMed 8854822Okamoto M, Furuichi S, Nishioka Y, Oshikawa T, Tano T, Ahmed SU, Takeda K, Akira S, Ryoma Y, Moriya Y, Saito M, Sone S, Sato M. Expression of toll-like receptor 4 on dendritic cells is significant for anticancer effect of dendritic cell-based immunotherapy in combination with an active component of OK-432, a streptococcal preparation. Cancer Res. 2004 Aug 1;64(15):5461-70. doi: 10.1158/0008-5472.CAN-03-4005.
PubMed 15289356Oshikawa T, Okamoto M, Ahmed SU, Tano T, Yoshida H, Sato M. [Anti-cancer effect of an intratumoral injection of dendritic cells expressing TLR4 in combination with an active component of OK-432 in TLR4-deficient mice]. Gan To Kagaku Ryoho. 2004 Oct;31(11):1770-2. Japanese.
PubMed 15553710
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study on Intratumor Dendritic Cell Injection Immunotherapy Using Immature Dendritic Cells With S Pyogenes Preparation (OK-432) for Patients With Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00795977
- Acronym / sponsor ID
- 198
- Conditions
- Pancreatic Cancer
- Keywords
- preoperative, intratumor, dendritic cells, pancreatic cancer, OK-432
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fukushima Medical UniversityUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 21 Nov 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 purpose of this study is to confirm safety and immunological responses of Preoperative intratumor dendritic cells injection immunotherapy using immature dendritic cells with S pyogenes Preparation (OK-432) for patients with resectable pancreatic cancer for pancreatic cancer patients.
Detailed description
The prognosis of pancreatic cancer is extremely poor even with extensive surgery, and development of new treatment modalities is much-expected for cure of this disease. Dendritic cells (DCs) immunotherapy is expected favorable outcome when it is approached directly to the cancer tissue. To evaluate safety and immunological responses, we conducted a phase I/II study of intra-tumor DCs immunotherapy for pancreatic cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dendritic cells | Experimental | Biological: dendritic cells, OK-432 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ECOG performance status 0-2
- Laboratory values as follows 3,500/mm3 <WBC<12000/mm3 Platelet count>100,000/mm3 T-Bil<2.0mg/dl BUN<25mg/dl, Creatinin<1.5mg/dl, 24h Ccr>50ml/min Normal ECG
- Able and willing to give valid written informed consent
Key exclusion criteria (7 listed)
- Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- Breast-feeder
- Active or uncontrolled infection
- Active or uncontrolled other malignancy
- Steroids or immunosuppressing agent dependant status
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 |
|---|---|---|
| dendritic cells, OK-432Single Group Assignment | Biological | dendritic cells |
Primary outcome
To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with OK-432
Time frame: 2 years
2 secondary outcomes
To determine the overall response rate for this regimen as determined by overall and disease-free survival.
Time frame: 2 years
To evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2011.
- Background: PubMed 16309221Kanzaki N, Terashima M, Kashimura S, Hoshino M, Ohtani S, Matsuyama S, Hoshino Y, Kogure M, Oshibe I, Endo H, Saito T, Yaginuma H, Gotoh M, Ohto H. Understanding the response of dendritic cells to activation by streptococcal preparation OK-432. Anticancer Res. 2005 Nov-Dec;25(6B):4231-8.
- Background: PubMed 8854822Takekuni K, Sakon M, Kishimoto S, Amano M, Sekimoto M, Aoki T, Oosato H, Dohno K, Umeshita K, Gotoh M, Monden T, Monden M. [A patient with unresectable cancer of pancreas head, effectively treated by a local injection of the mixture of OK-432, fibrinogen and thrombin]. Gan To Kagaku Ryoho. 1996 Sep;23(11):1621-3. Japanese.
- Background: PubMed 15289356Okamoto M, Furuichi S, Nishioka Y, Oshikawa T, Tano T, Ahmed SU, Takeda K, Akira S, Ryoma Y, Moriya Y, Saito M, Sone S, Sato M. Expression of toll-like receptor 4 on dendritic cells is significant for anticancer effect of dendritic cell-based immunotherapy in combination with an active component of OK-432, a streptococcal preparation. Cancer Res. 2004 Aug 1;64(15):5461-70. doi: 10.1158/0008-5472.CAN-03-4005.
- Background: PubMed 15553710Oshikawa T, Okamoto M, Ahmed SU, Tano T, Yoshida H, Sato M. [Anti-cancer effect of an intratumoral injection of dendritic cells expressing TLR4 in combination with an active component of OK-432 in TLR4-deficient mice]. Gan To Kagaku Ryoho. 2004 Oct;31(11):1770-2. Japanese.
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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.
Mitsukazu Gotoh, MD & PhD study chair
Fukushima Medical University, Department of Surgery 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dendritic cells, OK-432 in people with Pancreatic Cancer, run by Fukushima Medical University at 1 site in Japan.
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 7 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: status not confirmed, as of the sponsor's last update on 8 Sep 2011. 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 Japan. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with OK-432 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00795977, which also lists 4 linked publications.
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 Sep 2011.