Pancreatic NeoplasmsNCT00100321
Surgery for Pancreatic Tumors and Collection of Tumor Tissue for Study
An observational study of Pancreatic Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will examine pancreatic tumor tissue and immune cells from patients with a pancreatic tumor to look for markers on these cells that may be useful in developing new treatments for the disease. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2004to 20 Nov 2012
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient greater than or equal to 16 years of age with radiographic or endoscopic evidence of a pancreatic mass, ampullary mass or malignant stricture without evidence of distant metastases.
- Recovered from any serious toxicity experienced during previous treatment (chemo-, radiation, hormone, immuno-, etc., therapy) for pancreas cancer to a grade 2 or less.
- ECOG Performance Status greater 0-2.
- Must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to surgery.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Immunologic Studies of Tumors of the Pancreas
This study will examine pancreatic tumor tissue and immune cells from patients with a pancreatic tumor to look for markers on these cells that may be useful in developing new treatments for the disease.
Patients 16 years of age and older with any evidence of a primary pancreatic tumor that can be surgically removed may be eligible for this study. Types of pancreatic tumors included in this trial are pancreatic cancer, adenosquamous carcinoma, anaplastic carcinoma, IPMN (intraductal pancreatic mucinous neoplasm), acinar cell carcinoma, pancreaticoblastoma, mucinous cystic neoplasms, serous cystic neoplasms, solid-pseudopapillary cystic neoplasms, squamous cell carcinoma, Vater (ampullary tumors) duodenal adenoma or cancer and common bile duct tumors (cholangiocarcinoma.) The specific type of tumor does not have to be determined before the operation. Candidates are screened with a medical history and physical examination, computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen, and pelvis, blood and urine tests, and an electrocardiogram. Patients older than 50 years of age and patients with a history of cardiovascular disease may also have a thallium cardiac stress test.
Read more
Participants undergo standard treatment for their pancreatic tumor, including surgery to remove the tumor. Before, during, and after the operation, several blood samples are drawn as part of routine patient care and for research tests. During the surgery, a small piece of tumor tissue is taken for examination under the microscope and to grow cells in the laboratory for tumor and immune cell studies. Some patients may undergo leukapheresis to collect large numbers of white blood cells for study. For this procedure, blood is collected through a needle in an arm vein and flows through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The white cells are extracted and the rest of the blood (plasma, red cells, and platelets) is returned through another needle in the other arm.
Patients who require additional treatment, such as chemotherapy or radiation, may be treated at NIH on another protocol or referred for appropriate treatment elsewhere.
Read the detailed description
Background:
- Effective standard treatment options are currently not available for exocrine pancreas carcinomas. Adenocarcinoma of the pancreas, the most frequent exocrine tumor, is the fourth leading cause of cancer related deaths in men or women in this country.
- Immunotherapy for melanoma as studied in the Surgery Branch has resulted in striking tumor regression in some patients.
- Procurement of lymphocytes and tumor from patients with pancreas cancer will facilitate the identification of tumor-associated antigens leading to rational extensions of adoptive therapy and vaccination directed against this disease.
Objectives:
- Primary Objective: To obtain tissue, both tumor and lymphocytes, which can be used to identify tumor antigens specific to the various histologies of pancreas and ampullary cancer along with the HLA restricted epitopes of these antigens.
- Secondary Objective: To treat patients with resectable pancreas neoplasms using standard pancreatic resection and follow for survival.
Eligibility:
- Any patient greater than or equal to16 years of age with radiographic or endoscopic evidence of a pancreatic mass, ampullary mass or malignant stricture without evidence of distant metastases
- Patients must have an ECOG performance score of 0-2.
- Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.
Design:
- A tissue acquisition trial in which tissues will be obtained at the time of surgical operation for the resection of pancreas exocrine tumors.
- Tissue will be processed by the Surgery Branch Cell processing lab in accordance with their standard practices.
- No investigational therapy will be given.
- It is anticipated that 180 patients will be enrolled over 7 years.
- Conditions
- Pancreatic Neoplasms
- Keywords
- Tumor Antigen Identification, Standard Treatment, Tissue Acquisition, Surgery, Adjuvant Chemotherapy, Pancreatic Cancer, Pancreatic Tumor
- Medical subject headings
- Pancreatic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2004 (estimated)
- Study start21 Dec 2004
- Study completion20 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Observational
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Udo Rudloff, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100321
- Sponsor's protocol ID
- 050044
- Other IDs
- 05-C-0044
- Status last verified
- 20 Nov 2012
- First submitted
- 28 Dec 2004
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Jemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26. doi: 10.3322/canjclin.53.1.5.
PubMed 12568441Parkin DM, Bray FI, Devesa SS. Cancer burden in the year 2000. The global picture. Eur J Cancer. 2001 Oct;37 Suppl 8:S4-66. doi: 10.1016/s0959-8049(01)00267-2. No abstract available.
PubMed 11602373Abbruzzese JL. New applications of gemcitabine and future directions in the management of pancreatic cancer. Cancer. 2002 Aug 15;95(4 Suppl):941-5. doi: 10.1002/cncr.10753.
PubMed 12209675
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Studies of Tumors of the Pancreas
- ClinicalTrials.gov ID
- NCT00100321
- Acronym / sponsor ID
- 050044
- Conditions
- Pancreatic Neoplasms
- Keywords
- Tumor Antigen Identification, Standard Treatment, Tissue Acquisition, Surgery, Adjuvant Chemotherapy, Pancreatic Cancer, Pancreatic Tumor
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 21 Dec 2004
- Study completion
- 20 Nov 2012
- First posted
- 29 Dec 2004 (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.
This study will examine pancreatic tumor tissue and immune cells from patients with a pancreatic tumor to look for markers on these cells that may be useful in developing new treatments for the disease.
Patients 16 years of age and older with any evidence of a primary pancreatic tumor that can be surgically removed may be eligible for this study. Types of pancreatic tumors included in this trial are pancreatic cancer, adenosquamous carcinoma, anaplastic carcinoma, IPMN (intraductal pancreatic mucinous neoplasm), acinar cell carcinoma, pancreaticoblastoma, mucinous cystic neoplasms, serous cystic neoplasms, solid-pseudopapillary cystic neoplasms, squamous cell carcinoma, Vater (ampullary tumors) duodenal adenoma or cancer and common bile duct tumors (cholangiocarcinoma.) The specific type of tumor does not have to be determined before the operation. Candidates are screened with a medical history and physical examination, computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen, and pelvis, blood and urine tests, and an electrocardiogram. Patients older than 50 years of age and patients with a history of cardiovascular disease may also have a thallium cardiac stress test.
Participants undergo standard treatment for their pancreatic tumor, including surgery to remove the tumor. Before, during, and after the operation, several blood samples are drawn as part of routine patient care and for research tests. During the surgery, a small piece of tumor tissue is taken for examination under the microscope and to grow cells in the laboratory for tumor and immune cell studies. Some patients may undergo leukapheresis to collect large numbers of white blood cells for study. For this procedure, blood is collected through a needle in an arm vein and flows through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The white cells are extracted and the rest of the blood (plasma, red cells, and platelets) is returned through another needle in the other arm.
Patients who require additional treatment, such as chemotherapy or radiation, may be treated at NIH on another protocol or referred for appropriate treatment elsewhere.
Detailed description
Background:
- Effective standard treatment options are currently not available for exocrine pancreas carcinomas. Adenocarcinoma of the pancreas, the most frequent exocrine tumor, is the fourth leading cause of cancer related deaths in men or women in this country.
- Immunotherapy for melanoma as studied in the Surgery Branch has resulted in striking tumor regression in some patients.
- Procurement of lymphocytes and tumor from patients with pancreas cancer will facilitate the identification of tumor-associated antigens leading to rational extensions of adoptive therapy and vaccination directed against this disease.
Objectives:
- Primary Objective: To obtain tissue, both tumor and lymphocytes, which can be used to identify tumor antigens specific to the various histologies of pancreas and ampullary cancer along with the HLA restricted epitopes of these antigens.
- Secondary Objective: To treat patients with resectable pancreas neoplasms using standard pancreatic resection and follow for survival.
Eligibility:
- Any patient greater than or equal to16 years of age with radiographic or endoscopic evidence of a pancreatic mass, ampullary mass or malignant stricture without evidence of distant metastases
- Patients must have an ECOG performance score of 0-2.
- Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.
Design:
- A tissue acquisition trial in which tissues will be obtained at the time of surgical operation for the resection of pancreas exocrine tumors.
- Tissue will be processed by the Surgery Branch Cell processing lab in accordance with their standard practices.
- No investigational therapy will be given.
- It is anticipated that 180 patients will be enrolled over 7 years.
Study design
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Any patient greater than or equal to 16 years of age with radiographic or endoscopic evidence of a pancreatic mass, ampullary mass or malignant stricture without evidence of distant metastases.
- Recovered from any serious toxicity experienced during previous treatment (chemo-, radiation, hormone, immuno-, etc., therapy) for pancreas cancer to a grade 2 or less.
- ECOG Performance Status greater 0-2.
- Must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to surgery.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 12568441Jemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26. doi: 10.3322/canjclin.53.1.5.
- Background: PubMed 11602373Parkin DM, Bray FI, Devesa SS. Cancer burden in the year 2000. The global picture. Eur J Cancer. 2001 Oct;37 Suppl 8:S4-66. doi: 10.1016/s0959-8049(01)00267-2. No abstract available.
- Background: PubMed 12209675Abbruzzese JL. New applications of gemcitabine and future directions in the management of pancreatic cancer. Cancer. 2002 Aug 15;95(4 Suppl):941-5. doi: 10.1002/cncr.10753.
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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.
Udo Rudloff, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms, run by National Cancer Institute (NCI) 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 0 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 17 Dec 2019. 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 was stopped early. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00100321, which also lists 3 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 17 Dec 2019.