Clinical Trials Currently Ongoing at White Plains Hospital | White Plains Hospital

Clinical Trials Currently Ongoing at White Plains Hospital

Breast:

ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: a phase III study (ALTERNATE) (A011106)

A Cohort Study to Evaluate Genetic Predictors for Aromatase Inhibitor Musculoskeletal Symptoms (E1Z11)

A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Postmenopausal Patients with Hormone Receptor-Positive Advanced Breast Cancer (E2112)

The purpose of this study is find out what effects, both good and bad, an experimental drug called entinostat has on you and your cancer, when given together with the standard hormonal drug treatment, exemestane. Exemestane is an aromatase inhibitor which is used in breast cancer patients to inhibit (slow down) the growth of the breast cancer. In this study, patients will take exemestane, and either entinostat or an inactive substance (placebo). Entinostat is investigational and has not been approved by the Food and Drug Administration (FDA) for use in this cancer. If the patient is male, he will also receive Goserelin, a luteinizing hormone releasing hormone (LHRH) agonist that is used to suppress the production of testosterone and estrogen.

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer (NRG-BR003)

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 (S1207)

Renal:

EVEREST: Everolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study (S0931)

The purpose of this study is to see whether treatment with everolimus after surgery for kidney cancer will increase the time without cancer returning. The current standard treatment after surgery is careful monitoring with no immediate treatment. Studies suggest that one way kidney cancer may grow is through chemical signaling through a protein named “mTOR.” Everolimus is a drug that stops signaling through mTOR and may therefore stop the growth of kidney cancer. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for use after surgery. In this study, patients will get either everolimus or placebo (a pill with no medication).

Lung:

Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC) (A081105)

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) (A151216)

A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein (E4512)

Lung Biopsy: Next Generation DNA Sequencing of Malignant Tumors Obtained by Lung Biopsy: A Prospective Clinical Registry

White Plains Hospital Lung Cancer Screening Program (WPHLCSP)

Pancreatic:

Early Detection for Pancreatic Adenocarcinoma in Patients at Elevated Risk (PCEDP)

A Phase IIB Clinical Trial of the Anti-Angiogenic Drug Combination TL-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment (TLH-206)

The purpose of this study is to see if the investigational combination of drugs called TL-118 (the investigational drugs) given alongside Gemcitabine is effective in treatment of metastatic pancreatic cancer patients, and if people can tolerate taking it without it making them too sick. Investigational (experimental) drugs are drugs that are being tested in people but have not been approved by the U.S. Food and Drug Administration (FDA) for treatment of the studied disease.

Multiple Myeloma:

Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma (E3A06)

This research study is being done because there is no current therapy proven to benefit patients with high-risk (abnormalities in your blood or bone marrow) asymptomatic myeloma, a type of blood cell cancer that has not yet damages body tissue and organs to the point where symptoms are noticeable. These patients are not treated unless their disease progressed to symptomatic myeloma. The purpose of this study is to find out what effects (good and bad) the use of the drug lenalidomide has on patients and their multiple myeloma, and to compare this with patients that receive no therapy. Currently, the accepted treatment for asymptomatic myeloma is to receive no therapy.

Melanoma:

A Randomized Phase II Trial of Ipilimumab with or Without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma (E3612)

The purpose of this research study is to compare the good and bad effects of using the study drug called ipilimumab either alone or in combination with the study drug called bevacizumab. This regimen could help improve how long patients are able to live with their cancer, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach used to treat advanced melanoma. Ipilimumab is approved by the FDA at a dose of 3 mg/kg for a total of 4 doses given 3 weeks apart for metastatic melanoma that is not able to be surgically removed. Bevacizumab is not approved by the FDA to treat melanoma, and is an experimental treatment.

Prostate:

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer (S1216)

The purpose of this study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone. The combination of TAK-700 and standard hormone therapy is considered experimental.TAK-700 is a pill that works by reducing the levels of testosterone and other male hormones that help your prostate cancer grow. TAK-700 acts on the adrenal glands and inside the prostate tumors and slows the amount of male hormones being produced. By lowering the amount of male hormones in the body, TAK-700 is expected to control the growth of prostate cancer.

Newly Diagnosed:

Dietary Education and Livestrong® Exercise Program Study (DEALS-EPS)

The purpose of this research is to study how nutrition education and exercise affect newly diagnosed cancer patients. The researchers are also testing to see if starting an exercise immediately upon starting cancer treatment is better or worse than starting an exercise program one year later.

This research is being conducted because physician researchers think that nutritional intervention and exercise may improve outcomes and well-being of cancer patients. This is a randomized study which means participants will be randomly assigned to an arm of the study. Patients on Arm A will receive nutrition education and participate in the Livestrong® at the YMCA program within 6 months of starting cancer treatment. Patients on Arm B will receive nutrition education immediately but will wait one year to start the Livestrong® at the YMCA program.

Supportive Care:

A Randomized Placebo Control Trial for Pain Management in Cancer Patients Using Best Supportive Care for Pain Management With or Without Rocktape

The purpose of this study is to see if Rocktape can be used in cancer patients as a possible treatment for pain management. The physician researchers also want to see if Rocktape will help decrease pain and disability from lymphedema. Lymphedema is swelling caused by reduced blood and lymph fluid circulation. This is a blinded clinical trial which means participants will not know if they are receiving Rocktape or a different type of tape (placebo tape).

Pilot Evaluation of Tommie Copper Material and Its Impact on Pain Control

The purpose of this study is to see if copper-infused Tommie Copper clothing can be used for patients as a possible treatment for pain management. This is a blinded clinical trial which means neither the participant nor the doctor will know if they are receiving the copper-infused clothing or an identical clothing item produced without the copper.

Screening / Early Detection:

Lung Cancer Screening Program (IELCAPS)

This study will involve getting an annual CT examination. A CT of the chest is a test that uses special x-ray equipment to collect images from different angles around the body and then uses computer processing of the images to show a cross-section of body tissues and organs. Participants might qualify for this study if they are between the ages of 50 and 75, are a current or former smoker with at least a 20 pack-year history (the equivalent of smoking one pack a day for 20 years), and have no symptoms suspect of lung disease such as chronic cough. If participants are former smokers, they must have quit within the past 20 years.

This research is being conducted because physician researchers think it is possible that annual CT screening will enhance the possibility of early detection of lung cancer and that for those in whom lung cancer is diagnosed earlier this would lead to a higher cure rate.

Pancreatic Cancer Early Detection Program (PCEDP)

The purpose of this research is to study how well magnetic resonance imaging (MRI) and endoscopic ultrasound (EUS) screening of the pancreas can detect early pancreatic cancer for people who are at high risk of developing this cancer. An EUS is a procedure that allows a doctor to obtain images and information about the digestive tract and the surrounding tissue and organs. Ultrasound testing uses sound waves to make a picture of internal organs. Anesthesia is given prior to this procedure. A doctor will insert a small ultrasound device on the end of a tube into the mouth and use that device to take pictures of the inside of the body. Participants will undergo a baseline testing of an EUS followed by an MRI 6 months later. They will then be tested every six months if over age 65 or every 12 months if under age 65 and testing will alternate between and MRI and EUS.