Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer

NCT01492907 | Completed Phase 1

• 1 other identifier: 2011NTLS016
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Keywords

Heterocyclic amine carcinogens; meat-borne carcinogens

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Quantify [14C]MeIQx-DNA adducts in human pancreas

  4-8 Hours Post MeIQx Administration

• Quantify ambient adducts in the human pancreas

  4-8 Hours Post Administration

Study Arms (2)

Healthy Control Participants

ACTIVE COMPARATOR

age/sex matched normal controls - the subject will swallow a capsule with a dietary relevant dose of MeIQx

Radiation: MeIQx

Pancreatic Cancer Patients

ACTIVE COMPARATOR

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

Radiation: MeIQx; Procedure: Pancreatectomy

Interventions

MeIQx RADIATION

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.

Also known as: [14C]-MeIQx (2 Amino-3,8-dimethylimidazo[4,5 f]quinoxaline-2-[14C])

Healthy Control Participants; Pancreatic Cancer Patients

Pancreatectomy PROCEDURE

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

Pancreatic Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer cases are eligible for participation if all of the following criteria are met:
• \. 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pancreatectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Kristin E. Anderson, Ph.D.

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 15, 2011
• Study Start: January 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 22, 2014

Record last verified: 2014-08

Locations

US (1)