Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492907
• Other study ID #: 2011NTLS016
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2011
• Last updated: August 21, 2014
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: August 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Study Design:

This is a single institution pilot study to recruit 4 patients with operable pancreatic cancer scheduled for a pancreatectomy and 4 age/sex matched normal controls. Both groups will receive a single oral dose of radiolabeled MelQx followed by serial blood draws over an 8 hour period and urine collections over a 24 hour period. In addition, normal pancreatic tissue and normal small bowel tissue will be collected by Tissue Procurement from resected (waste) tissue at the time of pancreatectomy on the 4 pancreatic cancer patients.

Description:

This is not a therapeutic trial. It is an etiologic investigation of meat-borne carcinogens and possible role in pancreatic cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Cancer cases are eligible for participation if all of the following criteria are met:

• 1. Diagnosis or suspected diagnosis of pancreatic or periampullary cancer that is deemed to be operable and for which a pancreatectomy is planned.

• At least 18 years of age.

• Adequate hepatic function within 4 weeks of study enrollment defined as:

• Bilirubin = 2 mg/dl

• aspartate aminotransferase (ALT), alanine aminotransferase (AST), alkaline phosphatase = 2 the upper limit of normal (ULN)

• Females of childbearing potential or males whose partners are of child bearing potential are required to use an effective method of contraception (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 2 weeks after MelQx administration.

• Voluntary written consent before performance of any study-related procedure not part of normal medical care

Healthy controls are eligible for participation if all of the following criteria are met:

• Consider themselves generally healthy.

• At least 18 years of age

• Controls will be gender and age matched within 10 years of cases.

• Adequate hepatic function within 4 weeks of study enrollment defined as:

• Bilirubin = 2 mg/dl

• ALT, AST, alkaline phosphatase = 2 the upper limit of normal (ULN)

• Females of childbearing potential or males whose partners are of child bearing potential are required to use an effective method of contraception (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 2 weeks after MelQx administration.

• Voluntary written consent before performance of any study-related procedure not part of normal medical care

Exclusion Criteria:

Cancer cases are not eligible for participation if any of the following criteria are met:

For the purposes of this study to reduce the risk of recruiting a potentially unresectable patient:

• Tumor = 3 cm by scan

• CA-19-9 > 400

• Ascites

• Pregnant or lactating

• Uncontrolled chronic conditions such as: cardiovascular disease, hypertension, angina, congestive obstructive pulmonary disease (COPD) or other conditions which may alter metabolism, other than diabetes.

Healthy controls are not eligible for participation if any of the following criteria are met:

• Pregnant or lactating.

• Uncontrolled chronic conditions such as cardiovascular disease, hypertension, angina, COPD or conditions which may alter metabolism including diabetes.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• MeIQx
On the day of administration, the subject will swallow a capsule with a dietary relevant dose of MeIQx, 21 µg, labeled with a very low level of 14-carbon. The radioactive dose for MeIQx, 0.002 mSv (4.3 µCi), or less than an average dental x-ray.

Procedure:
• Pancreatectomy
Patients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center.

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Blood	Metabolite levels will be expressed as the percent of total recovered radioactivity in plasma. Metabolite profiles will be qualitatively compared between cases and controls, which will include the mean, median, standard deviation, range and 90% confidence interval for the major detoxification metabolites.	Pre MeIQx Administration, 1/2, 1, 2, 4, 6, 8 Hours Post MeIQx Administration	No
Primary	Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Urine	Metabolite levels will be expressed as the percent of total recovered radioactivity in urine. Metabolite profiles will be qualitatively compared between cases and controls, which will include the mean, median, standard deviation, range and 90% confidence interval for the major detoxification metabolites.	0-4, 4-8 and 8-24 Hours Post MeIQx Administration	No
Secondary	Quantify [14C]MeIQx-DNA adducts in human pancreas	In the pancreatic cancer patients, uninvolved/normal resected (waste) tissue from the surgery will be sent to Lawrence Livermore National Laboratory (LLNL) for DNA extraction following previously published methods. New [14C]MeIQx-DNA adducts formed at physiological concentrations will be detected and quantified in resected tissue with highly sensitive accelerator mass spectrometry (AMS).	4-8 Hours Post MeIQx Administration	No
Secondary	Quantify ambient adducts in the human pancreas	DNA adducts already present in resected tissue will be quantified and characterized with a newly improved technique, electrospray capillary high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS).	4-8 Hours Post Administration	No