The Role of Meat-borne Carcinogens in Pancreatic Cancer

University of Minnesota (UMN)

Status and phase: Withdrawn; Phase 1

Conditions: Pancreas Cancer

Treatments: Drug: PhiP

Study type: Interventional

Funder types: Other

Identifiers

NCT01092689

2007NT128

Details and patient eligibility

About

We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen binds to DNA in the pancreas.

Full description

Pancreatic cancer is rapidly fatal in most cases and little is known about its causes. Identifying and modifying risk factors can reduce mortality through prevention. Carcinogens that form in meat cooked at high temperatures may be modifiable risk factors for pancreatic cancer, but direct evidence is needed to demonstrate involvement in pancreas tissue. We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen binds to DNA in the pancreas. We hypothesize that the meat-derived carcinogen will bind to DNA in the pancreas. The amount of PhIP ingested is equivalent to the amount in two very well-done barbecued chicken breasts and the dose of radioactivity is comparable to a typical chest x-ray. This research can increase understanding of pancreatic carcinogenesis, facilitating the design of prevention strategies.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years old.
• Adequate hepatic function within 4 weeks of study enrollment defined as bilirubin ≤ 2 mg/dl and ALT, AST, and alkaline phosphatase ≤ 2 times the upper limit of normal.
• Females of childbearing potential or males whose partners are of child bearing potential are required to use an effective method of contraception (i.e., a hormonal contraceptive. intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 4 months after PhIP administration.
• Voluntary written informed consent (PhIP consent and Caffeine assay consent) before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.

Exclusion criteria

• CA-19-9 equal to or above 400.
• Tumor size >3.5 cm.
• Fluid in the abdomen (ascites).
• Conditions present, which, in the opinion of the surgeon, could make resection difficult, e.g., extensive vascular involvement.
• Pregnant or lactating (for women).
• Uncontrolled cardiovascular disease; e.g. hypertension, angina, etc.
• Patients who are intolerant of a 200 mg dose of caffeine or who otherwise do not wish to participate in the caffeine assay when consent is sought for the primary consent will be considered refusers and will not be enrolled in the study.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

PhIP

Experimental group

Description:

Prior to surgery, consented subjects will ingest a capsule containing \[14C\]PhIP. This amount of \[14C\]PhIP (84 micrograms PhIP; 15.6 micro-curies) is equivalent to that in 2 very well done grilled/barbecued chicken breasts (Sinha 1995); the amount of radioactivity is equivalent to the dose received in a commercial airline flying at 30,000 ft. for 5 h (HPS 2007) or to the amount received during a typical chest x-ray.

Treatment:

Drug: PhiP