Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Radiation: MeIQx Procedure: Pancreatectomy	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer Urine and Urination

U.S. FDA Resources

Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:

Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Blood [ Time Frame: Pre MeIQx Administration, 1/2, 1, 2, 4, 6, 8 Hours Post MeIQx Administration ] [ Designated as safety issue: No ]
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.
Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Urine [ Time Frame: 0-4, 4-8 and 8-24 Hours Post MeIQx Administration ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Quantify [14C]MeIQx-DNA adducts in human pancreas [ Time Frame: 4-8 Hours Post MeIQx Administration ] [ Designated as safety issue: No ]
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).
Quantify ambient adducts in the human pancreas [ Time Frame: 4-8 Hours Post Administration ] [ Designated as safety issue: No ]
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).

Estimated Enrollment:	8
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Healthy Control Participants age/sex matched normal controls - the subject will swallow a capsule with a dietary relevant dose of MeIQx	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. Other Name: [14C]-MeIQx (2 Amino-3,8-dimethylimidazo[4,5 f]quinoxaline-2-[14C])
Active Comparator: Pancreatic Cancer Patients Patients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center.	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. Other Name: [14C]-MeIQx (2 Amino-3,8-dimethylimidazo[4,5 f]quinoxaline-2-[14C]) Procedure: Pancreatectomy Patients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center.

Arms

Assigned Interventions

Active Comparator: Healthy Control Participants

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

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.

Other Name: [14C]-MeIQx (2 Amino-3,8-dimethylimidazo[4,5 f]quinoxaline-2-[14C])

Active Comparator: Pancreatic Cancer Patients

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

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.

Other Name: [14C]-MeIQx (2 Amino-3,8-dimethylimidazo[4,5 f]quinoxaline-2-[14C])

Procedure: Pancreatectomy

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

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492907

Contacts

Contact: Kristin E. Anderson, Ph.D.	612-626-8568	ander116@umn.edu
Contact: Lori Strayer	612-626-8885	strayer@umn.edu

Locations

United States, Minnesota
Masonic Cancer Center, University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Kristin E. Anderson, Ph.D. 612-626-8568 ander116@umn.edu
Principal Investigator: Kristin E. Anderson, Ph.D.

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

Investigators

Principal Investigator:

Kristin E. Anderson, Ph.D.

Masonic Cancer Center, University of Minnesota

More Information

No publications provided

Responsible Party:	Kristin E. Anderson, Ph.D., Principal Investigator, Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:	NCT01492907 History of Changes
Other Study ID Numbers:	2011NTLS016
Study First Received:	December 13, 2011
Last Updated:	January 4, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:

Heterocyclic amine carcinogens
meat-borne carcinogens

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 May 19, 2013