Carolinas HealthCare System
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Clinical Trials at Levine Cancer Institute

Levine Cancer Institute offers a wide range of clinical trials for adults and children. Trials allow us to greatly expand existing treatment options and bring advances in the study of new cancer therapeutics to patients more quickly.

Each phase of clinical trial generally has the following goals:

Phase 1 Trial Goals

  • To determine what dose is safe
  • To discover how a new treatment or combination of treatments affects the human body

Phase 2 Trial Goals

  • To discover how a new treatment or combination of treatments affects the human body
  • To determine if the treatment has an effect on a certain type of cancer

Phase 3 Trial Goals

  • To compare the study therapy to the current standard therapy

Less-common phases of clinical trials include:
Phase 0 – to determine if a therapy should move to phase 1
Phase 4 – to look at long-term safety and effectiveness

Visit us here to see current pediatric and adult cancer clinical trials.

Levine Cancer Institute’s Specialized Unit for Phase 1 Clinical Trials
Although Levine Cancer Institute has conducted phase 1 trials for many years, the opening of a specialized unit now allows our doctors to bring new cancer treatments to patients more quickly.

This special 4,000-square-foot unit has four beds and eight treatment chairs, and is staffed with researchers, physicians, physician assistants and Advanced Cardiovascular Life Support-certified nurses.

If standard cancer therapies have not worked to successfully treat your cancer, speak with your doctor about participation in a phase 1 clinical trial. Our team of physicians, nurses and other healthcare professionals can help you determine if you meet eligibility requirements.

For details about phase 1 clinical trials, call 980-442-2000.

Phase 1 Clinical Trials: Frequently Asked Questions

What is a phase 1 clinical trial?
During a phase 1 clinical trial, researchers are testing a new therapy or drug – or sometimes a new combination of drugs – with a group of participants. A phase 1 trial helps determine:

  • If the drug or drug regimen can be given safely
  • How often and how much of the therapy should be given
  • How the therapy should be administered (through a vein or by mouth, for example)
  • Whether there are side effects of the treatment

The main goal of a phase 1 study is to determine the best dose of therapy for further study, rather than to evaluate the drug’s effectiveness in treating cancer.

2. Will I qualify for a clinical trial?
Because of the investigational nature of phase 1 trials, they have very specific eligibility requirements and guidelines, so your participation cannot be guaranteed.However, Levine Cancer Institute is adding new clinical trials all the time. If you are not eligible for a particular trial, we encourage you let your physician know that you continue to be interested in clinical trials and the research team will work with you to find another trial. Search our clinical trials database here.

3. How do I become involved in a phase 1 clinical trial?
If you’re interested in participating in a clinical trial, talk with your healthcare provider. You can also call Levine Cancer Institute at 980-442-2000 to set up a consultation with a member of our phase 1 clinical trial team. You will need a referral from your provider and will be required to undergo eligibility screening.

Search our clinical trials database here. You may also download the Carolinas HealthCare System mobile app, and click on the Cancer Clinical Trials tab.

3. How soon can I start participating in a clinical trial?
How soon you are able to enroll in a clinical trial depends on trial availability. We will work to expedite an appointment for you to see one of our phase 1 physician specialists once you have contacted us.

4. What can I expect during a clinical trial?
When you take part in a clinical trial at Levine Cancer Institute, you are closely monitored by a team of physicians, pharmacists, nurses and a research coordinator to ensure your care is delivered and monitored according to rigorous standards.
This team will:

  • Assess your health before the start of the trial
  • Give you specific instructions on what to do during treatment
  • Watch your progress during the trial
  • Keep close contact with you after the trial is completed

Phase 1 clinical trials typically start with low doses of experimental therapy. Based on the specific trial, the healthcare team may increase doses slowly, typically in groups of patients, to monitor you for side effects and to determine the best dosage for future treatment studies.

Because the main purpose of a phase 1 trial may be to determine the maximum tolerated dose, there is the potential for side effects, some of which could be serious or even life-threatening. There is also no guarantee you will receive any benefit by participating in the trial.

Phase 1 clinical trials typically require more of a time commitment from participants – for example, more frequent trips to Levine Cancer Institute, longer hospital stays, lengthy visits or complex dosing requirements. You may also need to undergo a more demanding testing schedule, including blood tests, biopsies and scans.

5. Does insurance cover my care during a clinical trial?
Insurance companies are not mandated to cover costs related to participating in a phase 1 clinical trial, although your carrier may cover items such as testing or hospital expenses. The trial sponsor may cover some of your expenses. If any of your claims are denied, our financial counselors can help you file an appeal for coverage.

6. Can I leave a clinical trial?
Yes. Participation in trials is always voluntary, so you may discontinue therapy or completely withdraw from the trial at any time. However, we encourage you to discuss this with your doctors and the study team before discontinuing therapy or withdrawing from the trial.