Cancer Clinical Trials

Today's standard of care was yesterday's clinical trial. Consider clinical research.

University of Maryland St. Joseph Medical Center's (UM SJMC) Cancer Institute is an active partner in advancing the understanding and treatment of cancer through clinical trials and research studies of people who have cancer. The goal of these studies is to find better ways to treat, diagnose and prevent cancer so that people can live better and longer.

Clinical trials are the engine of cancer research and can represent a patient's best chance for effective therapy. The clinical trials offered at UM St. Joseph Medical Center include preventive, treatment and observational research studies. They are based on nationally approved standards of cancer care and are designed to research how we can best improve our patients' cancer outcomes.

Patients have access to national, investigator-initiated and industry-sponsored clinical trials. The UM SJMC research team can help determine if a treatment option is right for a particular patient. As with all clinical trials, patients who enroll must meet specific criteria. Clinical trials currently in process at UM SJMC's Cancer Institute are below.

"There are many great reasons to be part of a clinical trial," says Kimberly Schlesinger, MD, medical director of the Cancer Institute at UM St. Joseph Medical Center. "If you think a clinical trial may be right for you, talk to your doctor to learn more or visit clinicaltrials.gov."

Early Cancer Detection (Available to Patients with and Without Cancer)

• ctDNA Study A212102 – Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection – A study designed to help researchers evaluate and develop tests for early cancer detection. Blood and tissue samples will be collected from patients with cancer and without cancer.

Advanced Cancers

• A222004 – Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients – A randomized Phase III trial to compare olanzapine to megestrol acetate as an appetite stimulant in cancer patients who are suffering from loss of appetite

Breast Cancer

• TOL2506A – Ovelia: Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
  Patients in this study have been diagnosed with HR+, HER2-negative breast cancer while still being in a premenopausal hormone status (i.e., females with active ovaries that produce hormones that cause menstrual cycles, even if they are not regular). This is a phase III study to evaluate the effectiveness of a three-month course of leuprolide acetate for injectable suspension in combination with endocrine therapy to suppress ovarian function in these patients.

• A191901 – Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions – This study may help determine if using supportive text message reminders and/or telephone-based counseling can help encourage women to take their endocrine therapy medication as prescribed. Good medication adherence—or how well patients take the medication as directed by their doctors—may contribute to better health outcomes. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor-positive breast cancer patients.

• B-61 – A Phase III, Randomized, Open-Label, Multi-Center Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician's Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer. Endocrine therapy with tamoxifen or aromatase inhibitors (AIs [with or without ovarian function suppression (OFS)]) are currently the main endocrine treatment options for estrogen receptor-positive (ER+) early breast cancer (EBC). Despite the effectiveness of available therapies, many patients ultimately experience disease relapse or develop resistance to these agents. In addition, treatment-associated toxicity is an important major barrier to the full application of the current cancer treatment leading to treatment discontinuation in many patients. Consequently, there is a critical need for more optimal adjuvant therapy in patients with ER+ EBC, particularly for patients who have a high likelihood of recurrence.

Colorectal Cancer

• NSABP C-14: CORRECT-MRD II: Second Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease

Lung Cancer

• S1914 – A Randomized Phase III Trial of Induction / Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early State Non Small Cell Lung Cancer (NSCLC). This study compares treatment with eight cycles of Atezolizumab plus Stereotactic Body Radiation Therapy (SBRT) to SBRT alone in patients with high risk, early-stage NSCLC inoperable disease or where the patient is unwilling to undergo surgery.

Pancreatic Cancer

• A021806 – Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer – This study compares the effectiveness of chemotherapy given before and after surgery versus chemotherapy given after surgery for the treatment of pancreatic cancer that can be removed by surgery. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly) only.

  

Studies Currently in Active Follow-up

Please note: These studies are currently full and in active follow-up at UM St. Joseph. At this time, we are actively tracking study participants' progress and using what we learn to offer even safer, more effective and advanced treatment options for our patients.

Breast Cancer

• A011202 – Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy – A randomized phase III trial comparing axillary lymph node dissection to axillary radiation in breast cancer patients (CTI-3 N1) who have positive sentinel lymph node disease after neoadjuvant chemotherapy
• NSABP B-59 – Clinical Trial of Neoadjuvant Chemotherapy with Atezolizumab or Placebo in Patients with Triple-Negative Breast Cancer Followed after Surgery by Atezolizumab or Placebo – Patients in this study have a type of breast cancer called "triple-negative" and have not had any treatment or surgery to remove the cancer. Triple-negative means that your tumor is negative for the protein HER2 and is not sensitive to hormone treatment. This study may help determine if administering the experimental drug atezolizumab with chemotherapy, given before surgery (neoadjuvant therapy) for breast cancer, is better than administering a placebo with the chemotherapy.

• S-1207 – Hormone Therapy With or Without Everolimus in Treating Patients with Breast Cancer – The current standard treatment after chemotherapy is hormone treatment alone. This study may help determine whether treatment with everolimus plus hormone treatment after chemotherapy will keep patients cancer-free for longer. Everolimus is a drug approved for the treatment of patients with advanced or metastatic (or spreading) kidney or breast cancer.

• S-1418 – Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer – The purpose of this study is to compare the usual approach (no more treatment or additional chemotherapy and radiation therapy after surgery or radiation therapy alone after surgery), with any effects (good or bad) of receiving one year of therapy with the experimental drug MK-3475 (also called pembrolizumab) after surgery. This study will allow the researchers to better understand whether treatment with pembrolizumab is better, the same or worse than the usual approach alone.

Lymphoma

• RELEVANCE: Combined Rituximab and Lenalidomide Treatment for Untreated Patients with Follicular Lymphoma – Patients in this study have been diagnosed with follicular lymphoma (FL), which is a cancer of lymphocytes, a type of white blood cell. Recent studies suggest that rituximab plus chemotherapy followed by rituximab maintenance therapy is becoming a new standard of care for FL patients. This study involves the need to look for new treatments that may reduce the risk for recurrence or to prolong the disease-free time frame.

For more information about clinical trials at UM St. Joseph Medical Center and to learn more about how we can help patients access these important medical studies, please call our Office of Clinical Research at 410-427-2571.