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Listed below are brief descriptions of the clinical trials in which CentraState Medical Center currently is participating. For more information on any of the trials listed,contact CentraState's Research Department by telephone at (732) 303-5047 or send an e-mail.
The hospital currently has open clinical trials/research studies in the following areas:
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Behavioral
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Cancer (breast, gastrointestinal, lung, pancreatic, prostate, renal)
- Clostridium difficile-associated diarrhea (CDAD)
- Multiple sclerosis (MS)
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Pain relief
About Cancer Clinical Trials
The Comprehensive Cancer Program at CentraState Medical Center offers eligible patients the opportunity to participate in promising new developments in cancer treatment and prevention. CentraState is one of only three sites in New Jersey and one of only 60 sites nationally to be approved as a clinical trial site by the Cancer Trial Support Unit of the National Cancer Institute. CentraState Medical Center also is a clinical research affiliate and many of our physicians are clinical associate investigators of The Cancer Institute of New Jersey's Oncology Group. Our cancer clinical trials also are listed on the New Jersey Cancer Trial Connect website.
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Open Clinical Trials/Research Studies
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Breast Cancer
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1) Study Title: A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease Free Survival in Postmenopausal Women with Hormone Receptor Positive Cancer.
CSMC Protocol #: 2007-10
Other Sponsoring Protocol #: NSABP-B42
Principal Investigator: Jeffrey Silberberg, MD
Study Coordinator: Jennifer Beukers, RN
Description: To determine whether continuing hormonal therapy with an AI called letrozole for five additional years after already taking five years of hormonal therapy including an AI can further reduce the chance of breast cancer from returning.
Eligibility Criteria: Patients with a positive estrogen and /or progesterone (ER/PgR) hormone receptor test who have received five years of hormonal therapy.
2) Study Title: Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment
CSMC Protocol #: 2007-18
Other Sponsoring Protocol #: PACCT-1
Principal Investigator: Jeffrey Silberberg, MD
Study Coordinator: Jennifer Beukers, RN
Description: The goal is to determine whether patients who have a tumor with an Oncotype DX Recurrence Score of 11-25 benefit from chemotherapy and to confirm that patients who have a Oncotype DX Recurrence Score of less than or equal to 10 have a low risk of recurrence with hormonal therapy alone and do not need chemotherapy to reduce their risk of recurrence.
Eligibility Criteria: Patients who have adenocarcinoma of the breast who have had surgery fewer than 84 days from the date of the trial. They must be estrogen and/or progesterone receptor positive and axillary node negative. Patients may not have had prior chemotherapy, hormonal or radiation therapy, and should otherwise be in good health.
3) Study Title: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
CSMC Protocol #: 2009-21
Other Sponsoring Protocol #: NSABP B-43
Principal Investigator: Henry Tsai, MD, Sub-Investigators Edward Soffen, MD, Jeffrey Silberberg, MD, Aileen Chen,
Study Coordinator: Jennifer Beukers, RN 732-303-5047
Description: The primary objective of this study is to determine whether trastuzumab given during radiation therapy is more beneficial for preventing recurrence of ductal carcinoma in situ (DCIS; non-invasive breast cancer) that was removed by lumpectomy or the occurrence of invasive breast cancer in the skin or breast tissue of the same breast when compared to radiation therapy alone in women with HER2-positive (a protein that is overexpressed in some women with breast cancer).
Eligibility Criteria: Patients must be female, HER2 positive, 18 years of age or older, with an ECOG performance status of 0 or 1, with ductal carcinoma in situ (DCIS), isolated tumor cells ¡Ü 0.2 mm, resected by lumpectomy, with the interval between the last surgery for excision of DCIS and randomization no more than 120 days. Patients with a prior history of breast cancer or contralateral breast cancer including DCIS, invasive breast cancer, multicentric DCIS, breast irradiation administered before randomization, other malignancies unless disease-free for 5 or more years and at low risk for recurrence, prior anthracycline chemotherapy for any malignancy, cardiac disease that would preclude the use of the drugs included, uncontrolled hypertension, or pregnant/lactating at the time of study entry are inelligible.
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Gastrointestinal (GI) Cancer:
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1) Study Title: Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum
CSMC Protocol #: 2006-15
Other Sponsoring Protocol #: CALBG/SWOG C80405
Principal Investigator: Jeffrey Silberberg, MD
Study Coordinator: Jennifer Beukers, RN
Description: To determine whether cetuximab plus chemotherapy or cetuximab plus bevacizumab plus chemotherapy is better than the combination of bevacizumab with chemotherapy in treating patients with colorectal cancer.
Eligibility Criteria: Patients diagnosed with colorectal cancer who are not currently undergoing treatment.
2) Study Title: A Randomized Phase III Study Comparing 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers
CSMC Protocol #: 2007-09
Other Sponsoring Protocol #: ECOG E5202
Principal Investigator: Jeffrey Silberberg, MD
Study Coordinator: Jennifer Beukers, RN
Description: To determine whether adding bevacizumab to a standard combination of chemotherapy drugs (5-fluorouracil (5-FU), leucovorin and oxaliplatin) is better for treating colon cancer patients who may be at increased risk for recurrence based on markers shown in their tumor. Also, to see if adding bevacizumab will help prevent the cancer from coming back.
Eligibility Criteria: Patients who have had surgery to remove a tumor that extends through the wall of the colon, but is not found in the lymph nodes or any other organs.
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Lung Cancer
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1) Study Title: A Phase III Randomized Trial of Adjuvant Chemotherapy with or Without Bevacizumab for Patients with Completely Resected Stage 1B (less than or equal to 4cm)-IIIA Non-Small Cell Lung Cancer (NSCLC).
CSMC Protocol #: 2007-19
Other Sponsoring Protocol #: ECOG E1505
Principal Investigator: Jeffrey Silberberg, MD
Study Coordinator: Jennifer Beukers, RN
Description: The purpose of this study is to determine if adding the new drug bevacizumab to chemotherapy improves the chance for cure for patients who have had surgery to remove the lung cancer.
Eligibility Criteria: Patients who have undergone surgery no less than six weeks and no more than 12 weeks from starting the trial, and who have received no prior chemotherapy, hormonal or radiation therapy.
2) Study Title: A Phase III randomized trial of lobectomy versus sublobar resection for small (¡Ü2 cm) peripheral non-small cell lung cancer
CSMC Protocol #: 2009-09
Other Sponsoring Protocol #: CALGB 140503
Principal Investigator: HA Shakir, MD, Sub-PI SA Croce, MD
Study Coordinator: Jennifer Beukers, RN 732-303-5047
Description: The purpose of this clinical trial is to look at whether removal of a small section of lung (called a sublobar resection) is equal to a lobectomy (a larger surgery which takes out an entire section or ¡®lobe¡¯ of the lung, or about one-quarter to one-half of one lung, depending on which lobe is taken out) in patients who have small tumors with no evidence of spread. This clinical trial will be studying the overall effects (good and/or bad) of a sublobar resection (smaller segment of your lung) compared to a lobectomy (entire lobe of your lung).
Eligibility Criteria: Patients with non-small cell lung cancer peripheral lung nodules ¡Ü 2 cm on preoperative CT that are suitable for either lobar or sublobar resection, with an ECOG performance score of 0-2, and who are ¡Ý 18 years. Patients are not eligible if they have ground glass opacities or pathologically confirmed N1 or N2 disease; have had a malignancy within 5 years for which they have had chemotherapy or radiation therapy; or have evidence of locally advanced or metastatic disease.
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Prostate Cancer
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1) Study Title: A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy with Brachytherapy Alone for Selected Patients with Intermediate Risk Prostatic Carcinoma.
CSMC Protocol #: 2007-11
Other Sponsoring Protocol #: RTOG 0232
Principal Investigator: Edward Soffen, MD
Study Coordinator: Jennifer Beukers, RN
Description: To compare the effects of two different radiation treatments in patients with prostate cancer.
Eligibility Criteria: Patients who have been diagnosed with adenocarcinoma of the prostate who have had no previous chemotherapy or radiation therapy and the cancer has not spread to other parts of the body.
2) Study Title: A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy
CSMC Protocol #: 2008-09
Other Sponsoring Protocol #: RTOG 0534
Principal Investigator: Edward Soffen, MD
Study Coordinator: Jennifer Beukers, RN
Description: The purpose of this study is to compare the effects of three treatment methods: 1) Radiation therapy to the prostate bed only; 2) hormone therapy plus radiation therapy to the prostate bed; and 3) hormone therapy plus radiation therapy to the prostate bed and the pelvic lymph nodes. Patients will be randomly assigned to one of the three treatments.
Eligibility Criteria: Patients must be diagnosed with adenocarcinoma of the prostate and have had radical prostatectomy. The cancer must be localized to the prostate only and have a PSA level of more than 0.2 ng/ml and less than 2.0 ng/ml.
3) Study Title: A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer
CSMC Protocol #: 2009-15
Other Sponsoring Protocol #: RTOG 0815
Principal Investigator: Henry Tsai, MD, Sub-Investigator Edward Soffen, MD
Study Coordinator: Jennifer Beukers, RN 732-303-5047
Description: The primary objective of this study is to demonstrate an overall survival advantage for the addition of short-term (6 months) hormone therapy to dose-escalated radiation therapy for patients with intermediate-risk prostate cancer.
Eligibility Criteria: Patients must be age ≥ 18, confirmed prostate adenocarcinoma within 6 months prior to registration at intermediate risk for recurrence as demonstrated by one or more of the following intermediate-risk features: Gleason Score 7; PSA >10 but ¡Ü20; Clinical Stage T2b-T2c; negative lymph nodes; no evidence of bone metastases; and Zubrod Performance Status 0-1; and otherwise in good health. Patients with prior or concurrent invasive malignancy must be disease free for a minimum of 5 years. Patients with distant metastases, regional lymph node involvement, previous radical surgery or cryosurgery for prostate cancer, previous pelvic irradiation, prior or concurrent cytotoxic chemotherapy for prostate cancer, planned androgen deprivation or bilateral orchiectomy are ineligible.
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Multiple Myeloma
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Study Title: Randomized Phase III Trial of Lenalidomide and Low Dose Dexamethasone (LLD) vs Bortezomib, Lenalidomide and Low Dose Dexamethasone (BLLD) Multiple Myeloma.
CSMC Protocol #: 2009-16
Other Sponsoring Protocol #: SWOG S0777
Principal Investigator: Jeffrey Silberberg, MD; Sub-Investigator Aileen Chen, MD
Study Coordinator: Jennifer Beukers, RN 732-303-5047
Description: The purpose of this study is to compare the effects, good and/or bad, of two different combinations of drugs to evaluate whether they can stop or slow down the progression of multiple myeloma, and if so, which combination of drugs is more effective. Patients will be randomly assigned to take: 1) a two-drug combination (CC-5013 [lenalidomide], an experimental drug, and low dose dexamethasone, also called "LLD"); or 2) a three-drug combination (CC-5013 [lenalidomide], low dose dexamethasone, and an experimental drug called bortezomib ([Velcade®], also called "BLLD").
Eligibility Criteria: Patients are eligible who are ≥ 18 years of age, with newly diagnosed multiple myeloma (MM), with measurable disease, with non-secretory MM if the baseline serum Freelite is elevated, with Zubrod PS of 0-3, who are able to take ASA 325mg daily (or enoxaparin 40 mg SQ daily) as prophylactic anticoagulation. Patients who are pregnant, have received prior chemotherapy for this disease, have received prior radiation treatment to more than half of the pelvis, or had any prior treatment with bortezomib or lenalidomide are not eligible.
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Multiple Sclerosis Clinical Trial
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1) Study Title: Tysabri® Global Observational Program in Safety (TYGRIS)
CSMC Protocol #: 2008 01
Other Sponsoring Protocol #: Biogen Idec TYGRIS 101-MS-402
Principal Investigator: Amos Katz, M.D.
Study Coordinator: Michele Emmons, RN
Description: The purpose is to collect information on serious infections, cancers and other side effects that may occur with patients treated with Tysabri®
Eligibility Criteria: Patients enrolled in the TOUCH Prescribing Program who are being treated with Tysabri®.
2) Study Title: Pilot study to determine the effect of computerized brain-training in maintaining cognitive function in patients with Multiple Sclerosis.
CSMC Protocol #: 2009-07
Principal Investigator: Marilyn Abrahamson, MA, CCC-SLP
Study Coordinator: Marilyn Abrahamson, MA, CCC-SLP 732-637-6303
Description: This study is being done to measure the effect of using a computerized brain-training program on cognition in patients with multiple sclerosis in individuals with Multiple Sclerosis who have cognitive deficits.
Eligibility Criteria: Participants must be ages 20 - 70, diagnosed with multiple sclerosis, have cognitive deficits, be a registered participant in the CentraState Medical Center M.S. Wellness Program, or be a patient of one of the participating physicians of the CSMC Multiple Sclerosis Center, demonstrate successful participation in the Neurotrax Mindstreams® Assessment, and have regular access to a computer with internet capabilities.
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Pain Relief Clinical Trial
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Study Title: The Effect of Vaginal/Cervical Self Stimulation in Women with Chronic Pain
CSMC Protocol #: 2004-02
Principal Investigator: Janice Breen, PhD(c), APRN BC
Study Coordinator: Jennifer Beukers, RN
Description: Goal is to determine the effect of vaginal/cervical self-stimulation on pain detection and tolerance in women with chronic pelvic, abdominal or low back pain.
EligibilityCriteria: Women over age 18 who have chronic abdominal, pelvic or low back pain. Patients with a history of sexual abuse or mental illness are not eligible to participate
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