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 Committed to Excellence in Cancer Research, Education and Patient Care
Inroads
August 2020
Clinical Trial to Test Effectiveness of Drug in Treating Cancer Patients with Severe COVID-19
Dr. Nakhle Saba is principal investigator on the trial to treat severe COVID-19 in hospitalized cancer patients. (Photo by Paula Burch-Celentano)
"Cancer patients are at higher risk of developing severe complications from COVID-19," said Nakhle Saba, MD, associate professor of clinical medicine. "Data from the USA show that approximately 40% of COVID-19 patients with cancer required hospitalization, 20% developed severe respiratory illness, and 12% died within 30 days."

Despite this fact, cancer patients are often excluded from participating in clinical research trials for experimental COVID-19 treatments. This is due to a variety of factors in addition to their cancer diagnoses, including poor performance status and physiologic reserves (liver/kidney function, etc.) or the fact that they're taking cancer medications that prohibit them from being enrolled in trials.

"There is no standard of care or yet proven therapy for these patients, except remdesivir, which won't be widely available for some time, so trials are critically important to this population," said Saba.

In an effort to address this unmet need, Tulane has joined other institutions across the globe in a phase 1/2, double-blinded, placebo-controlled trial of the drug TL-895 to treat severe COVID-19 in hospitalized cancer patients.

TL-895 belongs to a relatively new drug class known as Bruton’s Tyrosine Kinase (BTK) inhibitors, which block a critical pathway within B-lymphocytes, the B-cell receptor pathway. Additionally, TL-895 inhibits bone marrow kinase (BMX), which plays a key role in NF-κB activation and the induction of pro-inflammatory cytokines, including IL-1β, IL-6, IL-8 and TNF-α. The same class of drugs is currently being used as a treatment for some leukemias and lymphomas. They are orally bio-available and overall well tolerated, including in older patients.

“Immune dysregulation in some COVID-19 patients, including patients with cancer, can result in an uncontrolled inflammatory response with subsequent lung damage and multi-organ failure,” said Saba. "Immune dysregulation doesn’t necessarily mean a weakened immune system; it could mean a dysfunctional immune system that's lacking some vital function that orchestrates the optimal response against the virus. A 'too much' reaction from the immune system can be devastating."

TL895 is not an anti-viral and will not attack the virus itself, according to Saba. The goal instead is to test whether the study drug can re-modulate the immune system, making it more efficient in clearing the virus while also decreasing the destructive inflammation the immune response is causing.

"The idea here is if you inhibit BTK and BMX you can reverse, at least in part, the inflammatory effect of the virus, especially in the lungs," said Saba.

This two-part trial is open to all hospitalized cancer patients with COVID-19, no matter the type of cancer. In part one, there is no placebo. All study participants will receive the study drug in different doses to see which is safest to proceed to part two. In part two, the recommended dosage from part one will be studied compared to placebo, with some patients receiving the study drug and others not.

TL895 is a pill taken twice daily in seven-day cycles. Unlike remdesivir or convalescent plasma, which are given intravenously, the patient can continue treatment orally at home if they improve to the point of being discharged from the hospital. "The beauty of this trial is that it does not exclude other approved or most commonly used therapies for COVID-19," said Saba. "For instance, the patients could be enrolled in this trial and also receive COVID-19 convalescent plasma, remdesivir and dexamethasone as treatments for COVID-19 at the same time."

Although Saba has high hopes the drug will be very well tolerated, this drug class has been known to cause bleeding, atrial fibrillation, diarrhea, skin rash, and musculoskeletal issues in some patients.

For more information, please contact Elise Tatje, senior clinical research coordinator, at 504-988-2987 or etatje@tulane.edu.
Join Us for our Virtual
Community Seminar on Prostate Cancer
Thursday, September 24
5 PM
Dr. Oliver Sartor, head of Tulane's Prostate Cancer Research Program, will discuss the very latest in prostate cancer research and treatment in this live virtual lecture. If you're interested in attending, please RSVP to Melanie Cross at mcross@tulane.edu. Login instructions will be sent to those who RSVP.
Gynecologic Oncology:
Diverse Team of "Women Caring for Women"
Jessica Shank, MD, chief of the Section of Gynecologic Oncology (left), and nurse navigator Mayra Gonzalez, RN (right) are part of a diverse team of "women caring for women" in Tulane's Gynecologic Oncology Program.
"Gynecological cancer is an intensely personal diagnosis," said Jessica Shank, MD, section chief of Gynecologic Oncology. "That's why I think it's so important to have a diverse team of women caring for women, from diagnosis to treatment to survivorship."

And that's what Tulane offers. From the surgeon to the radiation oncologists and therapists to the radiologist, pathologist, geneticist, pharmacists, nutritionist, clinical psychologist, nurses, financial counselors, social worker, new nurse navigator and beyond, Tulane has assembled a team of deeply dedicated women all focused on one goal - providing the highest level of care to Tulane Cancer Center’s gynecologic cancer patients.

"Many women want to see women, especially when it involves multiple pelvic exams or discussions of post-treatment sexual health," said Kendra Harris, MD, MSc, chair of Radiation Oncology.

"Some women have a history of sexual trauma that causes them to avoid pelvic exams, making them susceptible to have their cancer diagnosed later than we would like," said Dr. Shank. "Any barrier we can take away to help these women get the care they need sooner is a priority for us."
 
Convenient, Patient-Focused Care

"And so we've worked hard to create a comfortable space," said Dr. Harris. "We've reorganized our team with the patient at the center and with the goal of providing the highest level of coordinated care. Our patients can get nearly every service they need - chemotherapy, radiation therapy, nutritional, financial and psychological counseling- all under one roof, provided by close-knit team members who value coordinated care."

Central to the patient experience is new nurse navigator Mayra Gonzalez, RN. "Our patients tend to have to juggle several different appointments while they are undergoing treatment," said Dr. Shank. "It's Mayra's job to proactively assist in helping them stick to their treatment plans. She helps book appointments in a timely fashion, coordinates insurance authorization and approvals, and assists with getting them their medications. She's pivotal to our goal of coordinating care."
 
Where You Get Your Surgery Matters

Dr. Shank specializes in female pelvic cancers, including ovarian, Fallopian tube, primary peritoneal, uterine, cervical, vaginal and vulvar cancers, and she utilizes the latest minimally invasive surgical techniques, such as robotic assisted laparoscopy and laser surgeries.

"Where you get your surgery is important," said Dr. Harris. "You want a surgeon who is not only experienced, but also driving progress in the field. You also want to choose a surgeon who is as comfortable using a robot as performing open surgeries."

"The robot provides more dexterity," said Dr. Shank, who joined the Tulane faculty about a year and a half ago with a robust and high-volume practice under her belt. "It allows me as a two-handed surgeon to be a three-handed surgeon. It also has a 3D camera because it has two eyes, which gives me much better depth perception. I can get millimeters away from tissue to do fine dissection, which would be impossible while standing and looking into the abdomen."
 
Enhanced Recovery Protocol Gets Women Back to Their Normal Lives Sooner

In keeping the focus on patient-centered care, Dr. Shank and her team have developed a multidisciplinary protocol to enhance recovery and get women back to their normal lives or on to the next step of their cancer treatment as quickly as possible. With robotic or laparoscopic surgeries, incisions are smaller and most patients go home the day of or the day after their procedures, and many are back to work within two weeks. Central to the protocol is pain control. "We use a multi-modal pain approach, which helps minimize the use of narcotic pain medications," said Dr. Shank. "The truth is, narcotic pain meds don't treat pain; they just make you not care about the pain. But you build tolerance so you need more and more to achieve the same effect. Most of our patients are able to go home without needing any narcotic pain medications, which is extremely important considering the current opioid crisis."
 
Tumor Testing Provides Additional Insight

Another innovation the team has instituted is molecular and genetic testing for most gynecologic cancers. This involves sending tumor tissue samples to laboratories for genetic examination to see if patients might be candidates for very specific treatment options, such as PARP inhibitors, hormonal therapies, or newly developed immunotherapies. Patients are often also referred to a genetic counselor for germline testing, which is a blood test to look for hereditary causes of cancer. This information can be informative for families with an increased genetic risk for some cancers. The turnaround time for the testing is approximately two weeks.
 
Innovative Radiation Therapy Options

A brand new Oncentra treatment planning system allows Dr. Harris's Radiation Oncology team to give MRI-guided high-dose-rate brachytherapy to women with cervical and uterine cancers. Brachytherapy involves treating cancer through the insertion of radioactive implants directly into cancerous tissue.

"Specific to cervical cancer, this equipment eliminates the need for placement of a plastic cervical guide - or Smit sleeve - and reduces the number of required implants for curative therapy from five down to two," said Dr. Harris. "This would be for cervical cancer patients who are not candidates for surgery but can be cured through a combination of radiation and chemotherapy. These patients are typically younger and they often have kids, so minimizing the time away from home and organizing their care around what's best for them rather than what's convenient for us is pivotal."
 
Building a Program of Excellence

Dr. Shank, a native Louisianan, attended Tulane Medical School as a commissioned naval officer with a Navy Health Professions Scholarship. She then completed internship and residency in Obstetrics and Gynecology at Naval Medical Center San Diego (NMCSD), followed by a Gynecologic Oncology Fellowship at the University of Michigan. She then served as a staff gynecologic oncologist at NMCSD for five years before retiring from the Navy and returning to Tulane.

She says that one of the reasons she came home was the opportunity to build a program of excellence here. "We've developed a program that's largely of, by and for women while always keeping the special needs of our gynecologic cancer patients front and center. I'm proud of what we're building and what we have to offer the women of this area."
 
Appointments - On Both the North and South Shore

To make an appointment to see Dr. Shank in New Orleans, Metairie or at her new North Shore clinic, please contact Mayra Gonzalez, RN at 504-988-6509.