Clinical Trials

Clinical Trials

Today’s cancer treatments were yesterday’s clinical trials. In cancer research, a clinical trial is a study conducted with patients to evaluate a new treatment.

Investigational treatment can be a completely new drug, not yet approved for use or can be using an approved drug for a new indication, or in a different way.

Observational clinical trials are conducted to gain information from patients with a specific diagnosis or patients receiving specific treatment

The search for good cancer treatments begins with basic research. The best results of that research are tried in patient studies, hopefully leading to findings that may help many people. Many clinical trials are for observation purposes only. Before a new treatment is tried with patients, it is carefully studied in the laboratory. This research points out the new methods likely to succeed and, as much as possible, shows how to use them safely and effectively. But this early research cannot predict exactly how a new treatment will work with patients.

With any new treatment there may be risks as well as possible benefits. There may also be some risks that are not yet known. Clinical trials help us to find out whether a promising new treatment is safe and effective for patients. During a trial, information is gained about a new treatment, its risks and how well it may or may not work, by comparing it to “standard” therapy. Every clinical trial at CRMC goes through a careful process of reviews and approvals before it is opened for participation.

Only those patients who wish to participate take part in the clinical trial. You may be interested in or asked to enter a trial. Learn as much as you can about the trial before you make up your mind. You will be given a consent form to review and have all of your questions answered before deciding to participate in a clinical trial.

What is it like to be a patient in a clinical trial?
Whether cancer patients are in a research study or not, they face a new world of medical terms and procedures. For some people, myths and fears of “experimentation” or of being a “guinea pig” come with the idea of clinical trials. And there are fears of the unknown. Understanding what is involved can ease some of your anxieties. Patients in a clinical trial, for example, receive their care in the same places that standard treatments are given in The Cancer Center.

If you join a research study, you will be watched closely and data on your case will be carefully recorded. Certain tests can ensure an extra ounce of observation along the way. During the course of study, if it is clear that a treatment is not in your best interest, you will be removed from the study and you can discuss other options with your physician.

Can you leave a trial at any time?
Yes, just as you can refuse to join a study, you may leave a study at any time. Your rights as an individual do not change because you are a patient in a clinical trial. You may choose to take part or not, and you can always change your mind later even after you enter a trial.

You may also refuse to take part in any aspect of the research. If you have questions at any time about any part of a study, be sure to ask your doctors. If you decide to leave, it will not be held against you. You can freely discuss other possible treatments and care with your doctors and nurses.

The Cancer Center Clinical Trials Department has dedicated full time clinical trials staff:

  • Brandi Dietz, RN, BSN, Clinical Trials Research nurse coordinator, has 6 years' nursing experience and transitioned into the clinical trials role in 2015.
  • Linda Moore, BS,Clinical Trials data manager, has more than five years' oncology experience with the last three years being focused in clinical research.

If you are interested in finding out more about our clinical trials program or to learn more about current studies, please contact Brandi at 931-783-2714 or Linda at 931-783-5755. To view available clinical trials nationwide, visit www.clinicaltrials.gov.

 

Current Trials

Treatment

BREAST

SWOG 1207: Adjuvant Breast: Completion of adjuvant chemotherapy, pathologically negative lymph nodes, and a tumor measuring 2 cm in greatest      diameter, with an Oncotype DX recurrence score of >25 (completed as standard of care)

·       Schema: Phase III- randomized, placebo controlled, adjuvant endocrine therapy +/- one year of everolimus in high risk, hormone receptor positive and HER2/neu negative.

 

ACRIN A011104:  Female only, pathologically confirmed dx of breast cancer(needle bx only no surgical excisions), clinical stage I-II, or triple negative or Hormone Receptor negative with HER2 positive. No previous invasive DCIS, no bilateral Breast cancer, or no known BRCA mutations.

·       Schema: Effects of pre-op breast MRI on surgical outcomes, costs, and QOL of women with breast cancer. Stage I-II eligible for breast conserving therapy.

 

Spectrum SPI-2012:  Phase III, randomized, open- label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 with pegfilgrastim in breast cancer patients treated with TC chemotherapy.

·       Schema: Patients are randomized in a 1:1 ratio to 2 treatment arms: Arm 1: SPI-2012 / Arm 2:  Neulasta.

 

REP0114:   Randomized, double-blind, placebo-controlled phase 2 study of Paclitaxel in combination with Reparixin compared to Paclitaxel alone as front-line therapy for Metastatic Triple Negative Breast Cancer.

·       Schema: Randomized 1:1 into two treatment groups. Group one will have Paclitaxel on days 1, 8, & 15 along with the Reparixin tablets day 1-21 of 28 day cycle. Group two will have Paclitaxel on days 1,8, &15 along with placebo tablets day 1-21 of 28 cycle.

 

HEAD AND NECK

SCMP-8811-202:  A multicenter, randomized, placebo-controlled, double blinded study of the efficacy, safety, and pharmacokinetics of Cobiprostone for the prevention of severe oral mucositis in subjects with head and neck cancer receiving concurrent radiation and chemotherapy.

·       Schema: Randomized, placebo- controlled, double-blinded study of the efficacy, safety, and pk’s of Cobiprostone for the prevention of severe oral mucositis in head and neck cancer patients receiving chemo and radiation therapy.

LUNG

SWOG S1400- Lung Map:  Must have pathologically proven squamous cell lung cancer (NSCLC). Stage IIIb or IV. Must have received one front line platinum containing chemo regimen and evidence of disease progression.

·       Schema: Phase II-III biomarker driven master protocol for previously treated squamous NSCLC.

 

EMR100070-005: Phase III, open-label, multicenter trial of avelumab versus platinum based doublet as a first-line treatment of recurrent or Stage IV PD-L1+ NSCLC.

·       Schema: The availability of paraffin-embedded block containing tumor tissue, or unstained tumor slides. Looking for PD-L1+ tissue.  Must have one measurable lesion and histologically confirmed metastatic or recurrent NSCLC. Subjects must not have received treatment for systemic lung cancer.

LYMPHOMA

IPI-145-22:  Phase III, randomized, double-blind study of Duvelisib administered in combination with Rituximab and Bendamustine vs placebo administered in combination with Rituximab and Bendamustine in subjects with previously treated indolent Non-Hodgkin Lymphoma.

·       Schema: Subjects will be randomized 2:1 into the experimental and control arms. Arm 1 is the experimental arm (DBR). Arm 2 is control arm (PBR).  Randomization will be first stratified by disease subtype (FL,SLL, or MZL).

 

Non-Treatment

CANCER EXPERIENCE REGISTRY:  Open to all patients who have ever been diagnosed with cancer.

It is a movement designed to help us better understand the social and emotional needs of people living with cancer so that we and others can develop new resources that gives the support to the more than 12 million people touched by or living with cancer each year.

PROSTATE

Astellas ONC-MA-1004: A prospective observational cohort study of patients with castration-resistant prostate cancer. (CRPC).