Clinical trial NCT01492907: Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer
Official title: Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: Heterocyclic amine carcinogens
meat-borne carcinogens
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2011-12-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Eligibility 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.

Primary outcomes:
measure: Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Blood
timeFrame: Pre MeIQx Administration, 1/2, 1, 2, 4, 6, 8 Hours Post MeIQx Administration
measure: Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Urine
timeFrame: 0-4, 4-8 and 8-24 Hours Post MeIQx Administration
Secondary outcomes:
measure: Quantify [14C]MeIQx-DNA adducts in human pancreas
timeFrame: 4-8 Hours Post MeIQx Administration
measure: Quantify ambient adducts in the human pancreas
timeFrame: 4-8 Hours Post Administration
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Kristin E. Anderson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: