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Phase 1 Clinical Trials

At the Johns Hopkins Kimmel Cancer Center, our specialists are at the center of developing new therapies for cancer. Many of these emerging therapies originate from Kimmel Cancer Center research laboratories and continue to be evaluated as technologies and knowledge improve. The Phase I Clinical Trials Program connects patients at our cancer center to these pivotal early-stage studies, allowing them access to cutting edge therapies for their cancer.

What are Phase I clinical trials?

Phase I trials are the first in a series of four stages in testing new therapies in humans. At Johns Hopkins, these studies may involve treatments under development by pharmaceutical or biotechnology companies or those initiated by Johns Hopkins investigators with therapies being tested only at our institution. These trials may also test new combinations of already available drugs. The primary goal of these studies is to determine whether the therapy can be given safely, so one of the main evaluations is to watch for harmful side effects that may be caused by the treatment. Investigators also will try to determine the best way to give an experimental drug (e.g., by mouth, IV drip, or injection) and how often and how much should be given, called dosing. It is not the primary goal of Phase I clinical trials to test whether the experimental therapy is effective, but some studies may have secondary goals to look for how the drug combats the disease.

Phase I studies start at low doses and then escalate the doses slowly while monitoring patients for side effects to determine the optimal dose for the treatment. Accordingly, these studies carry a risk that patients may receive doses of treatment that are either lower or higher than the final recommended dose. Because little is known about how these drugs will be tolerated in humans, Phase I testing is done in a limited number of patients to minimize the risk of the experimental therapy. Patients enrolled in Phase I clinical trials are extensively monitored by the health care team and may require heavy time commitments and visits to the Johns Hopkins Kimmel Cancer Center. There are no placebos in Phase I clinical trials.

What are the risks and benefits of joining a Phase I clinical trial?

Patients enrolled in Phase I clinical trials often express their wish to make an important contribution in advancing new treatments for cancer. Phase I clinical trials offer access to therapies that are on the cusp of cancer research and have shown promise in laboratory testing. Patients enrolled in Phase I trials may receive doses of the experimental therapy that may not eventually be the final recommended dose if the therapy is successful in subsequent trials. Though most Phase I trials involve agents that have been tested in the laboratory on animals, there is less information on risks and side effects of the therapy in humans. Some studies may require extra visits to the Johns Hopkins Kimmel Cancer Center for blood tests, scans and biopsies.

When should I think about joining a Phase I clinical trial and who do I contact?

It may be appropriate to begin discussions about Phase I clinical trials after you have completed approved therapies for your cancer and are now looking for experimental treatments. The Phase I Clinical Trials Program helps determine whether patients may be suitable for Phase I trials and assists in connecting patients to the faculty and staff conducting the studies.

If you are a current patient at Johns Hopkins, please tell your provider that you are interested in clinical trials.

If you are not a patient at Johns Hopkins, please call our New Patient Referral Office at 410-955-8964 (press option 2, for medical oncology appointments) to arrange for a consultative appointment with a medical oncologist who can facilitate enrollment in the Phase I Clinical Trials Program.

How long does it take to enroll in a clinical trial?

Generally, it takes approximately 1 – 2 months to begin participation in a Phase I clinical trial if you are already a patient here at Johns Hopkins; external candidates may experience a short delay as they will need to be evaluated by one of our medical oncologists, and assessed for eligibility for a trial before referral to the phase I program. There may be required wait times between prior treatment and clinical trial-related treatment as defined by the study. There also may be delays because of the limited number of slots available in many clinical trials.

Steps:

For CURRENT Johns Hopkins cancer patients, joining a Phase I trial involves:

  1. A referral from the patient’s provider, which will be sent by the provider to the Phase I Clinical Trials Referral Nurse. The referral nurse will obtain specific details regarding the patient’s medical history to assess, on a basic level, whether the patient could be eligible for Phase I trials. The referral nurse will contact the patient to discuss particular trials.
  2. The patient will be referred to the nurse coordinating a specific trial to schedule a screening appointment that may involve further testing to make a final determination on eligibility for the clinical trial.
  3. Johns Hopkins faculty and staff will seek clearance from the patient’s insurance provider. This process averages 1 – 2 weeks, but may take up to 1 month. If coverage is denied, Johns Hopkins faculty and staff will seek an appeal. The majority of patients will eventually be approved for a clinical trial.

For patients NOT CURRENTLY receiving care at Johns Hopkins,

  1. Call Our New Patient Referral Office at 410-955-8964 (press option 2 for medical oncology appointments) to make a consultation appointment with a medical oncologist. Your medical team will be able to facilitate enrollment in the Phase I Clinical Trials Program.

What if I don’t qualify for a trial?

Because of the critical nature of early-phase clinical trials, each study has a specific and strict set of eligibility criteria, and many patients may not fit within those criteria. At the Johns Hopkins Kimmel Cancer Center, we are continually adding new phase I clinical trials to the range of studies available to patients. Patients who do not qualify for available Phase I clinical trials at a particular time may be reevaluated again when new trials are opened.

What if my insurance will not pay for treatment associated with a clinical trial?

Johns Hopkins clinicians may file for appeals with insurance companies when coverage for clinical trial-related treatment costs are denied.

Information for Referring Physicians and Johns Hopkins providers

Our team is committed to facilitating patient access to Phase I clinical trials and assisting principal investigators in their recruitment efforts. We provide an eligibility questionnaire that assists our team in matching patients to appropriate trials.

Our Team

Nilofer Azad, M.D., Assistant Professor of Medical Oncology and Chemical Therapeutics
David Cosgrove, M.D., Assistant Professor of Medical Oncology
Michael Carducci, M.D., Professor of Medical Oncology, Chemical Therapeutics
Kathy Elza-Brown R.N., Referral Nurse

For General Phase I Clinical Trial questions, please contact our Referral Nurse at 410-502-5140
FOR DISEASE SPECIFIC CLINICAL TRIAL QUESTIONS, PLEASE CONTACT THE DISEASE SPECIALTY CENTER DIRECTLY.

 

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