• Early Drug Development Center

    Dana-Farber/Brigham and Women's Cancer Care

    The Early Drug Development Center conducts phase I clinical trials of drugs that might become effective new treatments for cancer. If you decide to participate in a trial, we'll work closely with you and your treatment team to make sure you're well informed and safe at all times.

    About this Program

    In the Early Drug Development Center (EDDC), we conduct research dedicated to studying new drugs that might become safe and effective treatments for cancer. The EDDC specializes in conducting phase I clinical trials: small, carefully designed safety studies of experimental drugs that are being given to patients for the first time.

    Phase I trials enroll a small number of patients on a voluntary basis. The purpose is to determine a safe dose of the drug, and secondarily to observe whether the treatment has any beneficial effects.

    Participants in a phase I clinical trial may have access to some of the latest cancer treatments from pharmaceutical companies and scientists' research.

    How to become involved

    At Dana-Farber, your treatment team is based in one of the specialized disease centers for different types of cancers. You may be referred to the EDDC to discuss the possibility of volunteering for a clinical trial, but you will remain under the care of your original team.

    When you come to the EDDC, we will talk to you about participating in a phase I trial and provide you with specific information about what your participation will entail. We will make sure you, your family, and your treatment team understand all aspects of your involvement in the trial.

    The Early Drug Development Center's staff is devoted to pursuing excellence in the safe conduct of clinical trials for cancer with compassion and respect for everyone involved.

    Watch the video Entering a Clinical Trial: Is It Right for You? to learn more about participation in clinical trials.

    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.

    Treatment Team

    The Early Drug Development Center (EDDC) treatment team is comprised of a multidisciplinary group of medical oncologists, cardiologists, nephrologists, nursing staff and researchers who specialize in designing, conducting and analyzing clinical trials of experimental medicines to ensure that your treatment is closely monitored and safe. In addition, the EDDC targets disease-specific malignancies by collaborating with Dana-Farber clinicians across all treatment centers who are dedicated to improving your care with their expertise.

    Early Drug Development Center Clinicians

    Geoffrey Shapiro, MD, PhD, Disease Center Leader
    Andrew Wolanski, NP

    Disease Center Collaborators

    Nicole Chau, MD, Head and Neck Cancer Treatment Center
    James Cleary, MD, PhD, Gastrointestinal Cancer Treatment Center
    Leena Gandhi, MD, Thoracic Cancer Treatment Center
    Christopher Lathan, MD, Thoracic Cancer Treatment Center
    Jason Luke, MD, Melanoma Cancer Treatment Center
    Jeffrey Morgan, MD, Sarcoma and Bone Cancer Treatment Center
    Sara Tolaney, MD, Breast Cancer Treatment Center
    Andrew Wagner, MD, Sarcoma and Bone Cancer Treatment Center

    Program Nurse

    Brian Beardslee, RN

    Research Nurses

    Tracy Bell, RN
    Kimberly Shorey, RN
    Adrienne Anderson, RN
    Liz Wigozki, RN

    Clinical Research Manager

    Eveline Bordoli, PhD

    Assistant Clinical Research Manager

    Ketki Bhushan, MPH

    Senior Regulatory Coordinator

    Solida Pruitt-Thompson

    Senior Clinical Research Coordinator

    Illy Dixon

    Clinical Research Coordinators

    Dongpo Cai
    Kayla Murgo
    Matt Milstein
    Kathryn Haley
    Rudo Goto
    Matthew Hadfield
    Tatum Spagnoletti
    Minh Tran

    Regulatory Clinical Research Coordinator

    Christin Harrington

    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.

    Contact Us

    The Early Drug Development Center conducts phase I clinical trials for many types of solid tumor cancers. Patients and referring physicians are welcome to contact us for more information about current phase I clinical trials for cancer.

    If you are a patient interested in finding out more about phase I trials, please contact us using this secure online form.

    If you are a physician interested in referring a patient to a phase I trial, please contact us using this secure online form.

    Mailing address:

    Early Drug Development Center
    Dana-Farber Cancer Institute
    450 Brookline Ave.
    Floor 6
    Boston, MA 02215-5450

     
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