Phase I Cancer Clinical Trials

Oklahoma TSET Phase I Cancer Clinical Trials Program

The Oklahoma TSET Phase I Clinical Trials Program at OU Health Stephenson Cancer Center gives cancer patients first access to the newest early-stage investigational drugs. As the only Phase I clinical trials program in the state, Stephenson Cancer Center offers more trials than most other facilities. As a result, it is among the nation's top 10 Phase I programs.

Launched in partnership with one of the most extensive Phase I cancer clinical trial centers, Sarah Cannon Research Institute in Nashville, TN, the Oklahoma TSET Phase I Clinical Trial Program advances Stephenson Cancer Center's mission to raise standards of care for all Oklahomans. Participating in a Phase I clinical trial gives you access to a new generation of targeted therapies and helps researchers determine their effectiveness and safety.

The Phase I Program at Stephenson Cancer Center is named in recognition of the support provided by the Oklahoma Tobacco Settlement Endowment Trust (TSET). In addition, the National Cancer Institute or a pharmaceutical company sponsors clinical trials.

Advancing Cancer Treatments Through Scientific Research

Before they're widely available, new drugs, therapies and treatments must undergo strict testing to ensure safety. Phase I clinical trials could be very early "first-in-human" trials – this is the first step in testing the efficacy of a new treatment in humans after pre-clinical (laboratory) findings suggest the new drug or treatment is likely safe and effective in people or in a later stage combined with an already approved drug or in a specific cancer type. Nearly every cancer treatment available today was first tested in clinical trials including Phase I, II and III.

Phase I clinical trials test a new treatment’s safety, as well as:

• Identify the most effective administration method – orally or intravenously

• Determine if cancer responds to treatment

• Determine the best treatment timing

• Note any side effects

What to Expect from a Phase I Clinical Trial at Stephenson Cancer Center

If you or a loved one is interested in a Phase I clinical trial at Stephenson Cancer Center, talk to your oncologist, or contact the clinical trials office. We will discuss your medical history and together determine if your current condition meets the eligibility criteria — a set of rules that ensures your safety — by completing the following screening steps:

• Complete eligibility screening tests such as physical exam, electrocardiogram, blood and urine tests, and potentially other diagnostic tests required by the clinical research study.

• Consult with a Phase I research team member to discuss the drug and protocol, what to expect with monitoring and testing, and any known side effects.

• Ask questions about anything involving the trial and your potential participation.

• Sign the informed consent document.

Not all patients will meet the eligibility criteria for a specific Phase I clinical trial.

Participating in a Phase I Cancer Clinical Trial

When you choose to participate in a cancer clinical trial, you receive innovative treatments that may benefit your own condition, and help researchers make discoveries that can help many others.

You’ll receive a trial drug while your treatment team monitors for side effects through frequent blood draws and other diagnostic tests, depending on your situation. You’ll work closely with your cancer care team to ensure your maximum comfort throughout the trial, and you’ll benefit from frequent clinical visits to discuss any questions you may have along with monitoring your condition and progress.

Frequent diagnostic testing helps ensure your safety and can help doctors see how your body metabolizes the drug and predict how you will respond to treatment. In addition, the Food and Drug Administration (FDA) actively regulates Phase I, II and III clinical trials to ensure patient safety and proper consenting guidelines are followed.

You can continue with the scheduled phase I clinical trial protocol if it continues to benefit your condition.