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Clinical Trials Currently Open

Below is a list of clinical trials currently offered at the Cancer Institute of Florida Hospital Memorial Medical Center.
For any questions or to learn if you qualify for a trial, please contact our clinical trial research coordinators at (386) 231-4023 or (386) 231-4026.

A221101, “A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma.”

The purpose of this study is to: 
• See if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in patients who have been diagnosed with cancer and are experiencing fatigue.
• See the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue.

In this study, you will take either the study agent, armodafinil, or the placebo (inactive agent).  You will not take both. 
Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders.   However, it is not been studied in people with cancer related fatigue. 

A221301, “Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double-Blind, Placebo-Controlled Trial"

The purpose of this study is to test whether olanzapine can reduce nausea and vomiting. Olanzapine is a medication which has been approved by the Federal Drug Administration (FDA) for the treatment of specific mental illnesses and has been used in many patients over the past 15 years, but it is not FDA approved to treat nausea and vomiting. Over the past five years, it has been demonstrated in multiple scientific studies involving small numbers of patients to have anti-nausea and anti-vomiting effects in patients receiving chemotherapy. The purpose of this study is to determine if the use of this medication can significantly reduce nausea and vomiting in a large number of patients receiving chemotherapy. The effects of olanzapine will be compared to a placebo. A placebo is a pill that looks like the study drug but contains no medication.


SWOG S1207: “Phase III, Randomized Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer.

For women and men with hormone responsive (Estrogen or Progesterone Receptor positive) and Her 2 neu negative breast cancer  that has already been removed by surgery.  Chemotherapy or radiation therapy must have been completed.  
The purpose of this study is to see whether treatment with the drug Everolimus plus hormonal treatment after chemotherapy will possibly prevent or increase the time without your cancer returning (progression free survival).  The current standard treatment after chemotherapy is hormonal treatment alone.
Everolimus is a pill.  It is currently approved for the treatment of patients with advanced or metastatic  breast cancer.   In this study you will get the standard hormone treatment with either Everolimus or with placebo (a pill with no medication) for one year. The combination of hormone treatment and Everolimus is experimental in patients with breast cancer of your stage.

ECOG E2108:  A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer” (opening soon)

This trial is for patients who have cancerous tumor in the breast that has also spread beyond the breast to one or more other places in the body. When cancer spreads to another part of your body, this is called “metastatic disease.” The standard treatment for metastatic breast cancer is the use of chemotherapy, anti-hormone pills, or other medication.
When the cancer is no longer only in the breast and has spread to other areas of the body, surgery and/or radiation for the tumor in the breast cannot control the other areas of the cancer and are only used if the breast tumor is causing skin breakdown or pain, which happens only in some patients. For most people, the tumor in the breast is controlled with medicine and does not cause problems.
We do not know if local treatment (surgery and/or radiation) used early in the course of treatment of the breast cancer will help patients with metastatic breast cancer live longer or not. The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation for the tumor in your breast to the standard approach of continued treatment with the medication which is working to control your tumor. In this study, you will get either surgery plus radiation for your breast, or continue with the best medical treatment advised by your doctor. If you receive the standard treatment but the medicine is no longer controlling the tumor in the breast, and your doctor feels you need surgery or radiation, you may receive this when you need it.

S1007, "A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial RX for Positive Node, Endocrine Responsive Breast Cancer" – Step 2

The purpose of this study is to find out if the Oncotype DX® Recurrence Score can help doctors decide whether patients should receive chemotherapy or not.  This study is being done in patients with lower Recurrence Scores (25 or less). Most women who have the kind of breast cancer you have, are treated with endocrine therapy (treatment that works with hormones). Some women may also require chemotherapy in addition to the hormone therapy. No one really knows which patients with lower Recurrence Scores need to get chemotherapy. Some women may be getting chemotherapy that do not need it. These women may be exposed to side effects of their treatment that are not a necessary risk in relation to the benefit they receive.  All subjects in this study will receive hormone therapy but only some will receive both chemotherapy and hormone therapy.

RTOG #R1005: A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer  

The purpose of this study is to compare radiation therapy given with a higher daily dose over 3 weeks with a boost given each day of radiation therapy compared with standard whole breast radiation followed by a boost given on separate days which extends over 6 to 6 ½ weeks.  It is not expected that there would be a difference in survival by changing the number of daily treatments and shortening the length of time needed for treatment.  However, shortening treatment length could be more convenient and save time and money. It is not known, but it is hoped, that the higher daily dose of radiation to the breast has the same chance or better of preventing the breast cancer returning compared to standard daily doses of radiation.


Bristol Myers Squibb Observational Study Protocol CA184199:  A multi-site, prospective, observational study in US patients with Advanced Melanoma

The purpose of this study is to collect information about post-approval or “real world” experience on the treatment and management of advanced (unresectable or metastatic) melanoma. This will assess factors that influence disease management, patient safety, and patient outcomes.   Patients are also asked to complete questionnaires at several timepoints which reflect how they are feeling and coping with treatment.

The results of this observational study will provide a more complete understanding of the safety profile of Ipilimumab in a variety of oncology practices throughout the US,  including the dosing patterns, and information on the level of health care resources associated with the management of treatment.

Castle Bioscience:  Development and Validation of a Gene Expression Assay to Predict the Risk of  Metastatic Disease in Malignant Cutaneous Melanoma

A retrospective registry and specimen trial to develop a gene expression assay to predict the likelihood of metastasis in patients with stage I, II, III primary cutaneous melanoma.

ECOG #E1609: A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon α-2b for Resected High-Risk Melanoma

The purpose of this study is to compare the effects of ipilimumab (given at 2 different doses, 10 mg/kg or 3 mg/kg) with interferon alfa-2b to find out which is better for this stage of disease.  In this study, you will get ipilimumab (either at 10 mg/kg or 3 mg/kg) or the interferon alfa-2b. You will not get both.

High doses of interferon alfa-2b can reduce the risk of melanoma returning, but only some patients benefit from interferon.  We hope to find a more effective and long-lasting treatment for this stage of cancer.

Multi-Center, Double-Blind, Placebo-Controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-Resection Melanoma Patients with a High Risk of Recurrence

The purpose of the Polynoma Mavis study is to determine the safety profile and immunogenicity of two different doses of POL-103A 40µg or 100µg vs placebo in Part A of the study, and to determine the dose to be used in Part B of the study. The decision to proceed to Part B of the study will be based on evidence of immunogenicity, safety and tolerability. Part B allows an evaluation of efficacy using the dose of POL-103A selected from Part A.


SWOG S0819 Phase III Randomized Study of Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is compare the effects, good and/or bad, of the drug Cetuximab on lung cancer.   The study is looking at if you add this drug to the regimens above, does it improve overall survival for those with Non -Small cell lung cancer or not?
Cetuximab is a drug which was found several years ago to improve the response to treatment for patients with advanced colorectal cancer, and more recently in advanced head and neck cancer.  We are now looking at this drug in those patients with advanced non-small cell lung cancer.
You will be "randomized" to receive either chemotherapy without cetuximab or chemotherapy with cetuximab. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your doctor can choose the group you will be in. You will have an equal chance of being placed in either group to receive cetuximab or not.  The decision about whether you will receive bevacizumab will be made by you and your doctor based on several considerations related to your health history.