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Early Drug Development Center Clinical Research and Trials

  • Clinical Research

    All currently approved medical treatments for cancer will have started out as phase I studies to evaluate their safety.

    Specialists in the Early Drug Development Center (EDDC) are carrying out research on exciting new ways to kill tumors or halt their growth by attacking very specific abnormalities that aren't present in normal cells. Such experimental treatments could prove to be less toxic than current therapies.

    The EDDC has initiated more than 30 promising phase I studies of drugs that block molecular "switches" causing cancer cells to grow uncontrollably.

    Many of these studies have defined the proper dose and schedule for the treatment under evaluation, and have proven that the drug actually hit the misbehaving switch within the patient's tumor.

    Phase I Clinical Trials

    What is a phase I clinical trial?

    Clinical trials of new cancer drugs go through various phases in the development of a new treatment.

    First, there must be some evidence, either from laboratory or animal testing, or from other studies, that a new drug might be effective against a particular type of cancer. This evidence might come from a drug company or from a doctor who is already working in research.

    The goals of a phase I study are to find out:

    • How much of a new drug can be given safely
    • How often the drug needs to be given
    • What are the side effects of the new drug

    A phase I study will usually finish when the maximum dose that can be given safely has been determined.

    If there is evidence that the drug has some promise for treating cancer, it will be studied in a phase II setting using the phase I recommended dose. The goals of a phase II study are to continue to gather information about the safety of the drug and to test whether or not the drug works against a specific kind of cancer.

    If the drug continues to show promise in the phase II setting, the research will progress to a phase III trial. Phase III trials are much larger and will enroll hundreds, or even thousands of people to compare the effectiveness of the new treatment with either a placebo or an existing treatment.

    What happens in a phase I trial?

    Generally, the first people to join a phase I clinical trial for cancer are given a low dose of the drug. If they have no serious side effects, another small group of people is enrolled at a higher dose.

    This will continue until the highest safe dose is determined. Additional people are enrolled at that level to further study the safety of the drug.

    Throughout the study, the participants' health and the effect of the drug on their cancer are monitored carefully.

    What can I expect?

    Once you agree to take part in a clinical trial, you will meet your research nurse. The procedures you follow will depend on which study drug you are taking. You may be given tablets to take at home, or you may need to come into the clinic regularly for an intravenous infusion (through a needle in your arm).

    In most studies, you will need to come into the clinic on the first day and at regular intervals for blood tests and other procedures. Some will be quick visits (one to two hours); others may be much longer (10-12 hours).

    We will explain the details of your particular clinical trial before you sign the consent form. You will be given a detailed calendar outlining all the required study visits.

    Protecting patients in phase I clinical trials

    One thing to keep in mind about participating in a clinical trial is that the experimental study drug may not help your cancer. Also, because it is a new treatment, you may experience side effects of the drug that have not been identified yet.

    However, it is only by testing drugs through clinical trials that new and effective cancer treatments can be developed for the future.

    All research carried out at Dana-Farber must first be approved by the Institutional Review Board (IRB). The IRB is a group of experts and patient representatives who examine the scientific evidence for testing a new drug and, most importantly, look at the design of the study to make sure it is well planned and as safe as possible for participants.

    Research studies can only enroll participants once this approval has been granted. The IRB continues to monitor studies as they progress to check everything is being carried out safely and correctly.

    Learn more about clinical trials at Dana-Farber.