Clinical Trials

Winship key to four new myeloma drugs in 2015

lonial patientThe U.S. Food and Drug Administration (FDA) approved elotuzumab as part of an innovative immune-based therapy treatment for patients with relapsed multiple myeloma. This is the third myeloma drug approved by the FDA within the last month and the fourth new myeloma treatment approved within the last year. All four new agents were tested in clinical trials at Winship Cancer Institute of Emory University.

Sagar Lonial, MD, chief medical officer of Winship, says the potential of elotuzumab can be seen in the overall response rate as well as the longer duration of progression-free survival.

“The Winship multiple myeloma team has shepherded several of these treatments from the beginning stages of testing through to their approval,” said Lonial. “It’s a great source of pride to know we were instrumental in the process that has led to many more treatment options for our patients.”

Read the full press release here.

cta-learn-blue

Landmark Multiple Myeloma Studies from Winship

In recognition of September being Blood Caner Awareness Month, Dr. Sagar Lonial, Winship’s Chief Medical Officer shares a video about his Winship phase III clinical trial study on elotuzumab in treating myeloma patients.

Many cancers have benefited from FDA approvals for monoclonal antibodies (mAbs). Multiple myeloma, a second common blood cancer, had limited outcome improvements with mAbs until Dr. Lonial’s recent work. Dr. Lonial’s research was presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting and was published in the New England Journal of Medicine earlier this year.

Learn more about Winship Cancer Institute of Emory University.

No Patient Left Behind: Tracking Cancer Disparities

Veronica Reynolds' multiple myeloma is now in remission. She says Dr. Leon Bernal-Mizrachi "walked with me every step of the way. He's a great spirit. It doesn't matter who you are, you will be treated the same way."

Veronica Reynolds’ multiple myeloma is now in remission. She says Dr. Leon Bernal-Mizrachi “walked with me every step of the way. He’s a great spirit. It doesn’t matter who you are, you will be treated the same way.”

Why are some individuals more likely to develop cancer or to develop a more aggressive form of cancer? Winship clinicians and researchers confront such disparities daily – and are working to understand and change them.

Genetic research is a key to understanding how either race or ethnicity affect the incidence of different cancers and how these factors may contribute to different responses to the same treatments. Multiple myeloma, a blood cancer of the immune system’s plasma cells, occurs two to three times more often in African Americans than in Caucasians. Finding out why could lead to better therapies for all. Winship researchers couldn’t do it without people like Veronica Reynolds.

In her mid-50s, the busy realtor developed severe pain. She asked herself if she had strained her back, driving back and forth showing houses or picking up grandchildren? She told herself it would go away. It got worse. One doctor told her she looked too well to hurt as much as she claimed. Another believed her but his pills barely helped. After two years, she feared her heart would stop from pain. At Grady Memorial Hospital, imaging revealed fractured bones, due to bone destruction. Other tests provided the multiple myeloma diagnosis – and led Reynolds to Dr. Leon Bernal-Mizrachi, a Winship hematologist/oncologist who sees patients at Grady.

Reynolds credits God for sending her to Bernal-Mizrachi and to Dr. Jonathan Kaufman, director of Winship’s ambulatory infusion center, who oversaw her stem cell transplant following high dose chemotherapy. She credits herself for following the complex treatment regimens. And she’s “ecstatic,” she adds, about being part of her doctors’ research. “I hope I have enough fight in me to live to see it help many people like me.”

Reynolds – and her genes – are part of a massive multi-institutional study to sequence the entire genome (more than three billion DNA base pairs) of 1,049 African Americans with multiple myeloma and another 7,084 without the disease. The Winship component, headed by Drs. Sagar Lonial, Bernal-Mizrachi, and Ajay Nooka, has gathered almost a third of the study’s participants, thanks to the researchers’ commitment and Georgia’s high African-American population. Although still in process, the study is already producing valuable insights. Winship physicians routinely take tissue cells from multiple myeloma patients, looking for genetic variants that indicate who is at higher risk of relapse. They hope this new study will help identify why this disease occurs more frequently among African Americans and determine if there are treatments that may be specific to these patients.

The incidence of multiple myeloma in the African-American community is just one of the cancer disparities that Winship researchers are aggressively investigating. This blog is excerpted from a more comprehensive magazine article about health disparity research at Winship which can be accessed at https://winshipcancer.emory.edu/magazine/issues/2015/summer/features/no_patient_left_behind/index.html.

Winship Trial Reduces Mortality Rate for APL Patients

Winship's APL team (left to right): Martha Arellano, Kaitlin Sitchenko, Anand P. Jillella, Vamsi Kota, Ann Shen, Emily Bennett.

Winship’s APL team (left to right): Martha Arellano, Kaitlin Sitchenko, Anand P. Jillella, Vamsi Kota, Ann Shen, Emily Bennett.

Winship oncologist Anand Jillella, MD is spearheading a clinical trial for patients with Acute Promyelocytic Leukemia (APL) that could change the mortality rate for this disease on a major scale.

Often called the heart attack of leukemias, APL is a highly aggressive disease that is curable if treated early. A third of patients, however, do not survive the first month of treatment. By observing and analyzing the problem, Jillella and his team of physicians, nurses, and research staff came up with a collaborative approach that decreases mortality from 30 percent to about five percent. This new trial is open to patients all across the country.

Jillella has found that some physicians who treat patients with APL may not be familiar with the potential complications that can develop during treatment. He took a very detailed treatment algorithm and boiled it down to a three-step process that can be easily shared. “As soon as we get a call from a community physician, we send the simplified algorithm via smart phone,” says Jillella. “We come up with a treatment plan based on what the patient is experiencing and follow up with them regularly to get them through that difficult first month.”

RELATED RESOURCES:
Getting the Best Cancer Treatments into Outlying Communities
Clinical Trials: Leading the Way to Better Health Care

Winship Cancer Institute Expands Hospital Access

winship expands sign picWinship Cancer Institute has expanded access to its high quality cancer care in alignment with its broad clinical research program at both Emory Saint Joseph’s Hospital (ESJH) and Emory Johns Creek Hospital (EJCH). In addition, Winship has established the Winship Cancer Network as a means to improve access to such vital services throughout Georgia and the Southeast.

Longstanding and continued support from the Robert W. Woodruff Foundation has enabled Winship to advance cancer care and access to services like these for tens of thousands of patients throughout Georgia and beyond.

In addition to expanding services at ESJH and EJCH, the Woodruff Foundation’s most recent grant will be used to expand and improve Winship’s Shared Resource portfolio with special emphasis on its Cancer Prevention and Control Research Program. Researchers in this program are continually evaluating the best methods to reduce and eliminate the development of cancer among high-risk individuals across Georgia and the Southeast.

winship expansion banner

Related Resources
Emory Johns Creek Hospital
Emory Saint Joseph’s Hospital

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

winshiprostateblog1 banner

RELATED RESOURCES:

Recurrent Prostate Cancer: Where is it?

Tiffany Dunphy and Van Jackson, radiation therapists at Winship at Emory Saint Joseph's Hospital, work with prostate cancer patients undergoing radiation treatment.

Tiffany Dunphy and Van Jackson, radiation therapists at Winship at Emory Saint Joseph’s Hospital, work with prostate cancer patients undergoing radiation treatment.

“It’s a lot easier to plan the attack, if we know where the enemy is,” says Winship urologist Peter Nieh, MD. “If a cancer is still localized, we may want to try salvage therapy, either radiation or surgery, before advancing to something systemic.”

Depending on how primary treatment took place, a prostate cancer often comes back in the prostate bed (where the prostate gland was), and may appear in nearby lymph nodes. In advanced cases, the cancer may spread to the bones.

Emory radiologist and Winship member David Schuster, MD and radiochemist and Winship member Mark Goodman, PhD have been developing a PET (positron emission tomography) imaging probe that shows considerable potential for detecting recurrent prostate cancer.

Usually in PET imaging, radioactive glucose is injected into the body, and since cancer cells have a sweet tooth, they take up a lot of the radioactive tracer. But the tracer also appears in the urine, complicating prostate cancer detection efforts since the prostate is so close to the bladder. In contrast, the probe 18F-FACBC, based on amino acids, is taken up by prostate cancer cells but doesn’t appear as much in urine.

FACBC has its limitations. It also may be taken up in benign prostate hyperplasia or inflammation. This means it probably won’t be as useful by itself for evaluating primary prostate cancers, but it has a lengthening track record in recurrent cancer.

In a 2011 publication, Schuster and his colleagues compared FACBC to ProstaScint, a commercially available probe. FACBC showed superior sensitivity and specificity in detecting tumors outside the prostate bed. Schuster is now collaborating with Winship radiation oncologist Ashesh Jani, MD to study FACBC’s benefits in designing radiation treatments for patients with recurrent prostate cancer after prostatectomy.

In Jani’s clinical trial study for recurrent prostate cancer, which lasts until 2017, one group of patients is examined using FACBC, while another gets conventional imaging. The question is whether using information gleaned from FACBC to direct the radiation results in a longer lasting remission than with the control group.

Marble countertop salesman Paul Reckamp, who was a participant in Jani’s study, keeps a file on his phone noting his PSA levels for the last several years. Reckamp had a radical prostatectomy in July 2010 at Emory Saint Joseph’s Hospital, but the cancer appeared to come back a year and a half later. FACBC imaging confirmed that the cancer had appeared in nearby lymph nodes but not elsewhere, and doctors could then plan radiation treatment that drove his PSA levels back down again.

“I couldn’t have been more pleased with the study,” he says. “It told me and the doctors what we wanted to know.”

As a National Cancer Institute (NCI) designated cancer center, Winship Cancer Institute of Emory University’s participation in clinical trials ensures our prostate patients have access to progressive resources and technology. For men with recurrent prostate cancer, there are newer methods of imaging such as magnetic resonance imaging (MRI) and positron emission tomography (PET). 

winshiprostateblog1 banner

RELATED RESOURCES:

What is High Dose Rate Brachytherapy?

One of the most technically advanced and convenient options for cancer treatment is called high dose rate brachytherapy (HDR). It is a precise type of radiation therapy that is commonly used to treat localized gynecologic, lung, breast and prostate cancers that have not spread to lymph nodes. As opposed to low dose rate (LDR) brachytherapy, where tiny radioactive “seeds” are permanently placed inside or near a tumor, HDR brachytherapy involves temporarily placing high intensity sources of radiation inside the body with a catheter, for example, and then removing them once treatment is complete.

With short treatment and recovery times, HDR brachytherapy can help patients get back to their lives with minimal disruption. At Winship Cancer Institute of Emory University, the therapy is usually performed on an outpatient basis and carried out in two short sessions over one to two weeks. This results in an extremely precise radiation dose and minimal toxicity to the patient. Patients considering HDR brachytherapy may wonder if they will be radioactive following treatment. The answer is no. The radiation flows like the light that shines from a flashlight; it is not present once the treatment session is completed and the device used to deliver the radiation is removed.

HDR brachytherapy is performed at Winship locations by knowledgeable radiation oncologists with special expertise and certification in brachytherapy. The Department of Radiation Oncology at Winship is the only program in Georgia with advanced credentialing recognized by the National Cancer Institute for both LDR and HDR brachytherapy administration and expert usage.

Watch the short video below to learn more about how HDR brachytherapy is used to treat prostate cancer.

Find a Doctor

HDR Brachytherapy is performed at Winship locations by the following physicians:

For more information regarding HDR brachytherapy treatment at Winship Cancer Institute, please visit Emory Radiation Oncology.

In addition to regular treatments, 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. Read more>>

About Dr. Rossi

Peter Rossi, MDPeter Rossi, MD, is a board certified radiation oncologist and the Medical Director of Radiation Oncology at Winship at Emory St. Joseph’s Hospital. Dr. Rossi specializes in the treatment of prostate cancer, cervical cancer and ovarian cancer, and his expertise is in the use of external radiation therapy and brachytherapy for treating prostate and gynecologic tumors. Dr. Rossi is on the Quality Assurance Committee of the American Brachytherapy Society. He lectures, proctors and mentors physicians on the use of HDR brachytherapy for the treatment of prostate cancer at Winship and internationally.

Related Resources

Massage Therapy Used to Combat Breast Cancer-Related Fatigue

cancer and massage therapyFatigue is the most common side effect of cancer treatment according to the National Cancer Institute. Many breast cancer survivors describe their fatigue as more intense than the feelings of being tired that we all experience from time to time. Reported characteristics include feeling tired, weak, worn-out, heavy, slow, or lack of energy and difficulty getting-up-and-going.

Currently, researchers from Winship Cancer Institute of Emory University are investigating the benefits of massage therapy on breast cancer survivors with extreme fatigue.

“We decided to look at massage therapy for cancer fatigue because cancer-related fatigue is one of the most prevalent and debilitating symptoms experienced by people with cancer,” explains Mark Rapaport, MD, principle investigator for this study. “Many studies investigating massage for patients with cancer have been focused on depression, anxiety or pain.”

“We already know that frequent massage can enhance the immune system and reduce anxiety, and it has been reported that massage therapy can stimulate energy, and reduce symptoms such as nausea and pain,” says Mylin Torres, MD, associate professor in Emory’s Department of Radiation Oncology, serves as a co-investigator on the study. “We believe that there are many positive effects to be gained by therapeutic massage and we hope to prove that, among other biological advantages, massage may diminish the incapacitation that cancer-related fatigue can cause for our patients.”

Participants in the six-week study are post-surgery breast cancer patients, between the ages of 18 and 65, who have been treated with standard chemotherapy, chemoprevention and/or radiation, and are suffering with breast cancer-related fatigue. They are broken into three groups.

  • Group one receives a typical Swedish-type massage
  • Group two does not receive a massage
  • Group three receives a light touch massage.

Throughout the clinical trial, participants’ vital signs are taken and blood drawn to check for immune markers. The study staff also regularly checks in with each participant to record any changes in their life or their health. So far, the findings are promising.

View this Fox21 news clip to learn more about recent findings from the cancer fatigue trial!

 

Related Resources:

Cancer Clinical Study Leads to Video Tool for Prostate Cancer Patients

At Emory, research plays a key role in the mission to serve our patients and their families. Medical advances and improvements to patient care have been made possible by research and volunteer participation in clinical trials. More than 1,000 clinical trials are offered at Emory, making a difference in people’s lives, today.

Recently, a clinical study initiated by Winship Cancer Institute of Emory University, found that providing prostate cancer patients with a video-based education tool significantly improved their understanding of key terms necessary to making decisions about their treatment.

The breakthrough study was led by three Winship at Emory investigators; Viraj Master, MD, PhD, FACS; Ashesh Jani, MD; and Michael Goodman, MD, MPH; and is the feature cover story of this month’s Cancer, the peer-reviewed journal of the American Cancer Society.

In 2013, Master, Jani and Goodman released an Emory study that showed that prostate cancer patients (treated at Grady Hospital in Atlanta) experienced a severe lack of understanding of prostate key terms. The original study showed only 15 percent of the patients understood the meaning of “incontinence”; less than a third understood “urinary function” and “bowel habits”; and fewer than 50 percent understood the word “impotence.”

In response to their findings, the three principle investigators jumped to find a solution to the problem. The latest study explored using a video-based tool to educate prostate cancer patients on key terminology. The physicians predicted that with a better understanding of terms linked to disease, patients would be able to participate in shared and informed decision-making throughout the prostate cancer treatment process.

About the Prostate Cancer Video Trial:

  • 56 male patients were recruited from two low-income safety net clinics and received a key term comprehension test before and after viewing the educational video.
  • The video software (viewed by participants on iPads) featured narrated animations depicting 26 terms that doctors and medical staff frequently use in talking with prostate cancer patients.
  • Learn more by watching this video:

clinical trials for prostate cancer

Results of the Prostate Cancer Video Trial:

Participants who viewed the educational video demonstrated statistically significant improvements in comprehension of prostate terminology. For instance, before viewing the application, 14 percent of the men understood “incontinence”; afterward, 50 percent of them demonstrated understanding of the term.

“This shows that video tools can help patients understand these critical prostate health terms in a meaningful way. The ultimate goal is to give patients a vocabulary toolkit to further enable them to make shared and informed decisions about their treatment options,” says Viraj Master. “Our next goal is to improve the tool further, and study this tool at different centers.”

Learn more about clinical trials at Emory >>

Find a clinical trial at Emory >>

 

Additional Information about the Prostate Cancer Trial:

The research for this study was made possible by a Winship Cancer Institute multi-investigator pilot grant and the contributions of faculty and students from Winship, the Rollins School of Public Health and the Emory School of Medicine.

This study was led by three Winship at Emory investigators: Viraj Master, MD, PhD, FACS, Winship urologist and director of clinical research in the Department of Urology at Emory University; Ashesh Jani, MD, professor of radiation oncology in the Emory School of Medicine; and Michael Goodman, MD, MPH, associate professor of epidemiology with the Rollins School of Public Health.

Related Resources: