At the leading edge of hope, clinical trials combine research and patient care to improve and expand cancer treatment options. They give doctors the opportunity to learn more about investigational treatments—both new drugs and new treatment protocols for drugs already approved. They give patients additional prospects for improved outcomes and longer survival with therapies that would otherwise be unavailable. And, clinical trial participants know they are helping improve treatments for future cancer patients.

During 2005, Huntsman Cancer Institute (HCI) enrolled 419 patients in clinical trials originating both at HCI and at other cancer research facilities

Wallace Akerley, MD

nationwide. Highlights of some promising HCI-based trials follow:

Combretastatin A-4 phosphate (CA4P) is a vascular targeting agent that can destroy the blood vessels in tumors. Decreased tumor blood flow can slow or stop the growth and spread of the cancer. HCI, University of Utah, and pharmaceutical industry investigators collaborate on this Phase II trial conducted by Wallace Akerley, MD, senior director of clinical research. Investigators at HCI use CA4P together with conventional chemotherapy, then measure its effectiveness in blocking tumor blood flow in patients with advanced cancers.

Chronic lymphocytic leukemia is generally a slow-growing leukemia, but some patients with normal genes still have aggressive disease. This suggests that processes other than mutations and genetic abnormalities may play a role in leukemia growth. One of these processes is known as DNA methylation. Two clinical trials by HCI investigator Margaret Yu, MD, are designed to determine what and how DNA methylation contributes to chronic lymphocytic leukemia growth and if low doses of drugs that affect the methylation pathways can prevent progression of the disease.

Interleukin-2 (IL-2) can help stimulate the immune system and fight

Wolfram Samlowski, MD

metastatic melanoma. However, one side effect of this treatment often limits its use—IL-2 can cause extremely low blood pressure. A Phase I clinical trial by HCI investigator Wolfram Samlowski, MD, is assessing the safety of using a drug called PHP along with IL-2 to help minimize this side effect.

CLINICAL TRIAL PHASES

Phase I

• first-time test on humans
• establishes dose, schedule, and side effects
• no placebos; all patients receive a form of treatment
• small number of patients

Phase II

• uses dosage identified in
  Phase I
• tests drug’s effectiveness on
  specific kind and stage of cancer
• no placebos; all patients
  receive active treatment
• small number of patients

Phase III

• tests drugs proven effective in
  Phase II
• compares new treatment to standard
• patients randomly assigned to
  different treatments compared
  in study
• can include hundreds or thousands
  of patients enrolled at many locations