Posts Tagged ‘clinical trials for cancer’

A New Method to Find the Site of Returning Prostate Cancer

prostate cancer diagram

The yellow arrow and the white arrows on the pictures above indicate areas of prostate cancer that were invisible to previously available imaging techniques. Instead, they were detected using a new positron-emission tomography (PET) test called FACBC, which was developed and is being tested at Emory University.

A voluntary research study is being conducted to help men with recurring prostate cancer by using advanced imaging technology called FACBC to guide radiotherapy and determine the best possible course of treatment. This study would be added as an extra layer in your ongoing cancer treatment.*

We are looking for patients to participate in this clinical trial.

“By participating in this study, patients may have the opportunity to have an FACBC scan. The precision of this type of scan could help guide more effective treatment for patients whose cancer has returned,” says Ashesh Jani, MD, radiation oncologist and principal investigator.

Have you previously had surgery to treat prostate cancer, but think the cancer has returned? Has your doctor recommended radiation therapy as the next step in your care?

Participants must meet specific eligibility criteria:
• You are over 18 years of age.
• You had surgery (prostatectomy) to treat your prostate cancer.
• Your doctor suspects that the cancer has returned (as indicated by a rising PSA).
• Radiation therapy is now being considered as the next step in your care.

The trial is open at these locations: Winship Cancer Institute on the Clifton Road campus, Winship at Emory University Hospital Midtown, Winship at Emory Saint Joseph’s Hospital and Georgia Cancer Center for Excellence at Grady.

*You will be followed for a minimum of three years, with PSA levels checked every six months, in addition to having study-related lab work. There is no cost for the FACBC scan or the Food & Drug Administration (FDA) required lab work. All other imaging, lab work, biopsies (if any), radiation therapy and any other therapy will be billed to your insurance provider or paid out of pocket by you. You may be eligible for a travel voucher if you are chosen to undergo the FACBC scan.

For more information or to enroll, contact Ashesh Jani, MD, at (404) 778-3827 or abjani@emory.edu.

Learn more about Winship’s approach to Prostate Cancer Treatment
Read Winship’s Brochure on FACBC

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Progress and Thanks for Five Years of Phase I Clinical Trials

Phase I AnniversaryPatients.

Clinical trials.

We cannot have one without the other.

The Phase I Clinical Trials Unit at Winship Cancer Institute of Emory University opened in 2009, a time when a significant expansion of clinical trial efforts was underway to support the National Cancer Institute cancer center designation. Over this rapid five-year period, a truly collaborative culture has led to a cutting-edge, early drug development program at a nationally recognized, top 25 cancer center.

None of this has been possible without patients putting their trust in our physicians, nurses, scientists, and many others, to deliver optimal care while asking critical questions about novel drugs and approaches. When I think about the impact of our Phase I unit on patients and their families, I recall a recent conversation with a seasoned oncologist here at Emory. He said, “Donald, if I saw anyone in the chairs here at a store, I wouldn’t know they had cancer.” A simple statement, but one that conveys a number of key messages about how our phase I trials have evolved over five years. Drugs we now have at hand, as a whole, are much safer and better tolerated than conventional chemotherapy. We also have access to more agents with much better activity against cancer, leading to more treatment options.

With improved treatment comes a sense of satisfaction. However, we cannot over-emphasize the critical effect patients have on us as health care providers, researchers, and human beings. As a clinician-researcher, the greatest motivating factor I have is seeing patients do well on trials and coming to visits to talk about trips, family gatherings, important personal events, and the role that treatment on a trial had in helping them live their lives.

For this, we say thank you to our patients and their families for their trust and the courage they show on a daily basis. You keep up your fight, and we will keep up ours.

About Dr. Harvey

R. Donald Harvey, FCCP, BCOPR. Donald Harvey, PharmD, FCCP BCOP is director of the Winship Cancer Institute’s Phase I Clinical Trials section, and Associate Professor of Hematology and Medical Oncology at the Emory University School of Medicine. He is a Fellow of the American College of Clinical Pharmacy and a board certified oncology pharmacist. Widely published in peer-reviewed journals, Dr. Harvey’s research interests include the clinical application of pharmacokinetic, pharmacodynamic, and pharmacogenomic data to patient care.

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Phase I Trials – Where All Anticancer Drugs Begin

Donald Harvey, MD

R. Donald Harvey, PharmD, FCCP BCOP, director of the Winship Cancer Institute of Emory University’s Phase I Clinical Trials section

Each of the agents we use to treat cancer had a beginning, a first step, in understanding how safe and effective they might be.  As drugs are developed, we ask questions in different ways at each step, or phase, of testing. The National Cancer Institute reminds us that clinical trials are available for all patients at all points in their cancer journey, not just for patients with advanced cancer that is not responding to treatment.

When a drug is first given to patients, it enters testing in a phase I trial, where we ask questions such as:

  • What is the right dose?
  • How should it be given (e.g., by mouth, by vein, under the skin)?
  • What is the right schedule of treatment?
  • What side effects are there and how severe are they?
  • How often do we see side effects?
  • Where did the drug go in the patient? How well was it absorbed? How was it metabolized and/or eliminated? (Pharmacokinetics)
  • What did the drug do to the patient, both in blood and at the site of the cancer? (Pharmacodynamics)

Patients courageous enough to enter phase I trials are asked to do many time-consuming but important things during the trial. Frequently, patients are asked to spend 10-12 hours in our clinical trials unit and/or come in daily up to 14 times during the first treatment period, or cycle. During these visits, blood is drawn, tumor or bone marrow biopsies may be performed and safety tests are conducted, all in an effort to get a complete picture of drug effect, disposition and side effects.

Participation in phase I clinical trials:

To participate in a phase I trial, patients typically have cancer that has not been effectively treated with other therapies, and most trials require patients to be otherwise relatively healthy. Phase I trials usually enroll 10-40 patients, but may be larger or smaller depending on the questions being asked. Two types of phase I trials exist: those where the drug is being given for the first time, or first-in-human trials; and those where there is prior experience and the drug is given in combination with another drug or drugs (also called phase IB trials). In each, the investigational agent is given to small groups of patients, and doses are increased in each group. Both types are critical to the next step of development to define the dose, frequency, and understand what cancer types are most likely to benefit.

Phase I trials help to determine the future of drugs in cancer treatment. Right now, the large number of new agents in early testing indicates great potential in the transformation of therapy. People in good health may choose to participate in clinical trials simply to help researchers find better treatments. Participation in clinical trials is completely voluntary, but you should also speak with your physician before deciding to enroll.

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About Dr. Harvey

R. Donald Harvey, PharmD, FCCP BCOP is director of the Winship Cancer Institute’s Phase I Clinical Trials section, and Associate Professor of Hematology and Medical Oncology at the Emory University School of Medicine. He is a Fellow of the American College of Clinical Pharmacy and a board certified oncology pharmacist. Widely published in peer-reviewed journals, Dr. Harvey’s research interests include the clinical application of pharmacokinetic, pharmacodynamic, and pharmacogenomic data to patient care.