Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer

University of Minnesota (UMN)

Status and phase: Completed; Phase 1

Conditions: Pancreatic Cancer

Treatments: Radiation: MeIQx; Procedure: Pancreatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01492907

2011NTLS016

Details and patient eligibility

About

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.

Full description

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

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Healthy Control Participants

Active Comparator group

Description:

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

Treatment:

Radiation: MeIQx

Pancreatic Cancer Patients

Active Comparator group

Description:

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

Treatment:

Radiation: MeIQx

Procedure: Pancreatectomy