Clinical Trials at Northern Westchester Hospital
At Northern Westchester Hospital, we are committed to providing leading-edge treatments and clinical trials close to home. Our patients can benefit from major medical advancements previously found in big city hospitals, now in the comfort of our own community.
Click on a link below to view clinical trials at Northern Westchester Hospital:
We continue to expand the availability of clinical trials in Westchester, New York and Fairfield, CT. For more information on Northern Westchester Hospital Clinical Trials, click CONTACT US on the left, or call the Clinical Trials Director, Dr. Joshua Fink, at 914.666.1366.
SIPS Procedure OPEN
What: A prospective multi-center single-arm study of the Stomach, Intestinal and Pylorus Sparing Procedure (SIPS)
Who: Subjects who have elected to undergo bariatric surgery using the SIPS procedure (according to subject and investigator assessment and standard of care).
Why: The primary objective of this study is to evaluate excess weight loss at 12 months following the SIPS Procedure. SIPS is a single-anastomosis duodeno-intestinal switch procedure. Preliminary data from Sanchez-Pernaute et al. (Surg Obes Relat Dis 2013;9:731) indicates that this procedure is safe, quick to perform, and offers good results for treatment of both morbid obesity and its metabolic comorbidities. CovidienTM plans to further investigate this procedure and has proposed a prospective clinical study to obtain data on subject outcomes through 12 months following the SIPS procedure. Click here to learn more about the SIPS procedure.
What: The DCVax-L study is evaluating an experimental vaccine for its effectiveness in treating Glioblastoma brain tumors.
Who: This study is designed for patients diagnosed with a Glioblastoma tumor – a specific type of cancerous brain tumor.
Why: The DCVax-L study is evaluating an experimental vaccine derived from a patient’s own white blood cells that is believed to work with the patient’s immune system to target brain cancer cells.
NCT00892177 / N0872 CLOSED to new enrollment
What: Phase I and Randomized Phase II Double Blind Study of Either Dasatinib or Placebo Combined With Bevacizumab in Recurrent Glioblastoma.
Who: This study is designed for men and women who are 18 years or older with histological confirmation of grade 3 or 4 glioblastoma multiforme (grade 4 astrocytoma) as determined by pre-registration central pathology review; Note: Variant gliosarcomas are eligible.
Why: This randomized phase I/II trial (Phase I completed) is studying the side effects and best dose of dasatinib when given together with bevacizumab and to see how well it works compared to placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme.
Join Us: To see if you, or someone you may know, fit the criteria for the brain tumor clinical trials, please contact the Clinical Trials Coordinator at Northern Westchester Hospital: 914.666.1366, or click CONTACT US above.
Dana-Farber Young and Strong CLOSED to new enrollment
What: The Dana-Farber Young and Strong Program focuses on the needs of young women who have been diagnosed with breast cancer. This is an educational and supportive study and does not include any medications.
Who: Women between the ages of 18 and 45 who have been diagnosed with stage I, II or III breast cancer within the last three months.
Why: The purpose of this program is to address the gaps in care for young women with breast cancer as part of a larger effort to better understand breast cancer and to improve the care and outcomes for our younger patients. This study examines whether educational interventions focusing on issues unique to young women with breast cancer, combined with healthy lifestyles, can help to improve the care of young breast cancer patients. The investigators believe that concerns related to fertility, including body image, sexual dysfunction, and physical activity, can be addressed early in order to improve the satisfaction of care and quality of life for young women.
NSABP B47 CLOSED to new enrollment
What: The NSABP B47 study is a trial of adjuvant therapy comparing chemotherapy alone to chemotherapy plus trastuzumab in women with node-positive or high-risk node-negative HER2-low-invasive breast cancer.
Who: This study is designed for women who are 18 years or older that are not pregnant or nursing. To be eligible, the patient must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy) (patients who have had a nipple-sparing mastectomy are eligible).
Why: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread and others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer. The purpose of this study is to determine if adding a targeted therapy, trastuzumab, to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning.
MTF-13-02 CLOSED to new enrollment
What: The MTF-13-02 study is an aesthetic trial and a patient reported outcome trial for those who are undergoing Tissue Expander Breast Reconstruction utilizing a Flex Pliable HD skin graft after a mastectomy (unilateral or bilateral) for therapeutic or prophylactic reasons. Each patient will be in the study for 90 days. This study is limited to enrollment of 30 patients.
Who: This is a pilot study designed for women who are 18 years or older who are scheduled to undergo post-mastectomy tissue expander breast reconstruction.
Why: This study is being done because surgeons are trying to continually improve their patient's experience when a patient chooses to undergo breast reconstruction using tissue expanders. Tissue expanders are special balloons, which are placed in the breast at the time of your mastectomy. Their advantage is to act—along with the acellular dermal matrix—to increase the overall amount of tissue available to reconstruct your breast.
Paloma-2 (Formerly A5481008) CLOSED to new enrollment
What: The Paloma-2 study is a randomized, multicenter, double-blind Phase 3 study of Letrozole plus PD-0332991 versus Letrozole plus Placebo for the treatment of postmenopausal women with ER(+), HER2(-) Breast Cancer who have not received any prior systemic anti-cancer treatment for advanced disease.
Who: This study is designed for postmenopausal women who are 18 years or older with ER(+), HER2(-) locoregionally recurrent or metastatic disease and will be candidates to receive Letrozole as first-line treatment for their advanced disease.
Why: This study is being done to confirm the clinical benefit and superiority of the combination of PD-0332991 and Letrozole compared to Letrozole and Placebo in postmenopausal women with ER(+)/HER2(-) locoregionally recurrent or metastatic breast cancer
Paloma-3 (Formerly A5481023) CLOSED to new enrollment
What: The Paloma-3 study is a multicenter, randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of PD-0332991 (Palbociclib) in combination with Fulvestrant (Faslodex®) over Fulvestrant alone in prolonging Progression Free Survival (PFS) in women with hormone receptor positive (ER/PR), HER2(-) locally recurrent or metastatic breast cancer whose disease progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared.
Who: This study is designed for women who are 18 years or older with hormone receptor positive (ER/PR), HER2(-) locally recurrent or metastatic breast cancer whose disease progressed after prior endocrine therapy.
Why: This study is comparing the effects and demonstrating superiority between the two treatment arms in preventing further cancer growth. It will also study the safety of the study treatment.
Join Us: To see if you, or someone you may know, fit the criteria for one of our breast cancer clinical trials, please contact the Clinical Trials Coordinator at Northern Westchester Hospital: 914.666.1366, or click CONTACT US above.
INCYTE 18424-266 (NCT02119650) OPEN
What: This is a double-blind Phase II randomized study of Ruxolitinib or Placebo in combination With Pemetrexed/Cisplatin and Pemetrexed Maintenance for initial treatment of subjects with Nonsquamous Non-Small Cell Lung Cancer (NSCLC) that is stage IIIB, stage IV, or recurrent.
Who: This study is designed for both men and women between the ages of 18 and 75 with histologically or cytologically confirmed diagnosis of nonsquamous NSCLC.
Why: Part 1: To determine of the dose of Ruxolitinib that is safe and tolerable in combination with Pemetrexed/Cisplatin as measured by the number of dose-limiting toxicities (DLTs); Part 2: To track overall survival.
CheckMate 153 (CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 153) CLOSED to new enrollment
What: A phase IIIb/IV safety trial of nivolumab (BMS-936558).
Who: Patients with Stage IIIB, Stage IV, or with recurrent or progressive disease following multi-modal therapy (radiation therapy, surgery, or chemo-radiotherapy for locally advanced disease).
Why: The main objective of the study is to provide additional insight into the frequency of high-grade select adverse events and their outcome, and thus supplement the growing safety database of nivolumab-treated patients.
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST A151216) OPEN
What: The study seeks EGFR and ALK genotyping of non-squamous non-small cell lung cancer tissue.
Who: The study is designed for patients 18 years or older with no malignancies in the past five years, except non-melanoma skin cancer.
Why: To centrally genotype lung surgery patients for EGFR mutations and ALK rearrangements in order to develop adjuvant studies; advanced genomic analyses in conjunction with the NCI Center for Cancer Genomics (CCG).
ALCHEMIST A081105 OPEN
What: This is a 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).
Who: For patients who have gone through the ALCHEMIST Screening Trial A151216 (above) at first for the EGFR exon 19 deletions or L858R mutation.
Why: To assess whether adjuvant therapy with erlotinib will result in improved overall survival (OS) over placebo for patients with completely resected stage IB (≥4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy.
ALCHEMIST E4512 OPEN
What: This is 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.
Who: For patients who have gone through the ALCHEMIST Screening Trial A151216 (above) and determined to be ALK positive; and patients with Stage IB (≥ 4 cm)/II/IIIA NSCLC complete surgical resection.
Why: To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB ≥ 4cm, II and IIIA, ALK-positive NSCLC following surgical resection.
Join Us: To see if you, or someone you may know, fit the criteria for INCYTE or CHECKMATE lung cancer clinical trials, please contact the Clinical Trials Coordinator at Northern Westchester Hospital: 914.666.1366, or click CONTACT US above.
HOMER OMB113676 OPEN
What: A phase III randomized, open label study of single agent ofatumumab versus single agent rituximab in the treatment of indolent B-cell non-Hodgkin's lymphoma, relapsed after rituximab-containing therapy.
Who: This study is designed for adults 18 years or older with:
- lymphoma Grades 1, 2, 3 A
- Small lymphocytic lymphoma (SLL)
- Marginal zone lymphoma
- Lymphoplasmacytic lymphoma
Why: Rituxan (rituximab) is the current standard of care for patients with slow-growing lymphomas, such as non-Hodgkin's lymphoma. Although Rituxan is a highly targeted and well-tolerated lymphoma treatment, the remission rate is lower. Ofatumumab has induced remissions in patients with similar conditions, but has not yet been studied in lymphoma. The HOMER study seeks to determine whether ofatumumab alone can achieve improved outcomes.
CALGB 50901 CLOSED to new enrollment
What: The CALGB trial is a Phase II randomized trial comparing the use of high and low doses of ofatumumab for previously untreated patients with follicular non-Hodgkin’s lymphoma to determine whether higher or lower doses can achieve improved outcomes in patients with low-grade follicular NHL.
Who: This study is designed for adults 18 years or older with follicular non-Hodgkin’s lymphoma who have been previously untreated. Those that are pregnant or nursing are not eligible.
Join Us: To see if you, or someone you may know, fit the criteria for HOMER or CALGB lymphoma clinical trials, please contact the Clinical Trials Coordinator at Northern Westchester Hospital: 914.666.1366, or click CONTACT US above.
MEAL – Men's Eating and Living OPEN
What: The MEAL study, sponsored by the National Cancer Institute, focuses on whether a man's nutrition and diet can contribute towards the progression of prostate cancer.
Who: The MEAL study is designed for men who have been diagnosed with prostate cancer and have been placed on active surveillance, also known as the watch and wait approach. These men have not had chemotherapy, radiation or surgery.
Why: The MEAL study is designed to test whether a high-vegetable diet will lower the risk for prostate cancer progression compared to a “standard” diet. The MEAL study is crucial to our understanding of the possible relation between consumption of foods and food groups and the progression of prostate cancer.
Join Us: To see if you, or someone you may know, fit the criteria for the MEAL prostate cancer clinical trial, please contact the Clinical Trials Coordinator at Northern Westchester Hospital: 914.666.1366, or click CONTACT US above.
POINT : Platelet-Oriented Inhibition in New TIA, and minor ischemic stroke CLOSED to new enrollment
What: A prospective, randomized, double-blind, multicenter trial with the primary null hypothesis that, in patients with TIA or minor ischemic stroke treated with aspirin 50-325 mg/day, there is no difference in the event-free survival at 90 days in those treated with clopidogrel (600 mg loading dose then 75 mg/day) compared to placebo when subjects are randomized within 12 hours of time last known free of new ischemic symptoms.
Who: Patients 18 years of age or older with high-risk TIA, or minor ischemic stroke, who can be randomized within 12 hours of time last known free of new ischemic symptoms.
Why: To determine whether clopidogrel 75 mg/day by mouth after a loading dose of 600 mg of clopidogrel is effective in preventing major ischemic vascular events.
ORBIT AFib II : Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II OPEN
What: A phase ll trial designed to evaluate target-specific anti-thrombotic agents and direct thrombin inhibitors, and associated outcomes.
Who: Adults, 21 years of age and older, with AF (atrial fibrillation) diagnosed within the preceding 6 months; or (2) have initiated or transitioned to a FXa inhibitor or a direct thrombin inhibitor within the preceding 3 months.
Join Us: To see if you, or someone you may know, fit the criteria for the ORBIT stroke clinical trial, please contact the Clinical Trials Coordinator at Northern Westchester Hospital: 914.666.1366, or click CONTACT US above.
About The Clinical Trials Program at NWH
Joshua Fink, MD, is the Medical Director of the Clinical Trials Program at Northern Westchester Hospital, Mt. Kisco, NY.
Jonathan Goldberg, MD, is the Medical Director of the Cancer Clinical Trials at the Cancer Treatment and Wellness Center at Northern Westchester Hospital.
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