The Role of Meat-borne Carcinogens in Pancreatic Cancer

This study has been withdrawn prior to enrollment.
(Needed New IND per FDA)
Sponsor:
Collaborators:
University of Arkansas
Lawrence Livermore National Laboratory
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01092689
First received: March 23, 2010
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen binds to DNA in the pancreas.


Condition Intervention Phase
Pancreas Cancer
Drug: PhiP
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Understanding the Role of Meat-Borne Carcinogen in Pancreatic Cancer Etiology

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Quantify and characterize HCA-DNA adducts in resected human pancreatic tissue after a dietary relevant dose of PhIP, the most mass abundant HCA in charred meat. [ Time Frame: 6 hours post ingestion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantify [14C]PhIP and [14C]PhIP metabolites in urine and plasma. [ Time Frame: From 0 to 24 hours ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2012
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PhIP
Prior to surgery, consented subjects will ingest a capsule containing [14C]PhIP. This amount of [14C]PhIP (84 micrograms PhIP; 15.6 micro-curies) is equivalent to that in 2 very well done grilled/barbecued chicken breasts (Sinha 1995); the amount of radioactivity is equivalent to the dose received in a commercial airline flying at 30,000 ft. for 5 h (HPS 2007) or to the amount received during a typical chest x-ray.
Drug: PhiP
1 capsule of 84 micrograms; 15.6 micro-curies [14C]PhIP

Detailed Description:

Pancreatic cancer is rapidly fatal in most cases and little is known about its causes. Identifying and modifying risk factors can reduce mortality through prevention. Carcinogens that form in meat cooked at high temperatures may be modifiable risk factors for pancreatic cancer, but direct evidence is needed to demonstrate involvement in pancreas tissue. We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen binds to DNA in the pancreas. We hypothesize that the meat-derived carcinogen will bind to DNA in the pancreas. The amount of PhIP ingested is equivalent to the amount in two very well-done barbecued chicken breasts and the dose of radioactivity is comparable to a typical chest x-ray. This research can increase understanding of pancreatic carcinogenesis, facilitating the design of prevention strategies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old.
  • Adequate hepatic function within 4 weeks of study enrollment defined as bilirubin ≤ 2 mg/dl and ALT, AST, and alkaline phosphatase ≤ 2 times the upper limit of normal.
  • Females of childbearing potential or males whose partners are of child bearing potential are required to use an effective method of contraception (i.e., a hormonal contraceptive. intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 4 months after PhIP administration.
  • Voluntary written informed consent (PhIP consent and Caffeine assay consent) before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

  • CA-19-9 equal to or above 400.
  • Tumor size >3.5 cm.
  • Fluid in the abdomen (ascites).
  • Conditions present, which, in the opinion of the surgeon, could make resection difficult, e.g., extensive vascular involvement.
  • Pregnant or lactating (for women).
  • Uncontrolled cardiovascular disease; e.g. hypertension, angina, etc.
  • Patients who are intolerant of a 200 mg dose of caffeine or who otherwise do not wish to participate in the caffeine assay when consent is sought for the primary consent will be considered refusers and will not be enrolled in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092689

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
University of Arkansas
Lawrence Livermore National Laboratory
Investigators
Principal Investigator: Kristin E Anderson, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01092689     History of Changes
Other Study ID Numbers: 0712M23122
Study First Received: March 23, 2010
Last Updated: January 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
heterocyclic amines
PhIP
Meat
pancreas neoplasms

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014