The Role of Meat-borne Carcinogens in Pancreatic Cancer

NCT01092689 | Withdrawn Phase 1 DMC

• 1 other identifier: 2007NT128
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreas Cancer

Keywords

heterocyclic amines; PhIP; Meat; pancreas neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  6 hours post ingestion

Secondary Outcomes (1)

• Quantify [14C]PhIP and [14C]PhIP metabolites in urine and plasma.

  From 0 to 24 hours

Study Arms (1)

PhIP

EXPERIMENTAL

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

Interventions

PhiP DRUG

1 capsule of 84 micrograms; 15.6 micro-curies \[14C\]PhIP

PhIP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• University of Arkansas: collaborator
• Lawrence Livermore National Laboratory: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

2-amino-1-methyl-6-phenylimidazo(4,5-b)pyridine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Kristin E Anderson, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 25, 2010
• Study Start: January 1, 2012
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

US (1)