Listed below are brief descriptions of the clinical trials in which CentraState Medical Center is currently participating. For more information on any of the trials listed, contact CentraState's Research Department by telephone at (732) 294-5874 or send an e-mail to jbreen@centrastate.com.
The hospital currently has open clinical trials/research studies in the following areas:
• Behavioral
• Cancer (breast, gastrointestinal, lung, pancreatic, prostate, renal)
• Multiple sclerosis (MS)
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 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.
Open Clinical Trials/Research Studies
Breast Cancer
1) 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 ineligible.
Gastrointestinal (GI) Cancer:
1) Study Title: A Randomized Phase II Study of Irinotecan and Cetuximab with or without the Anti-Angiogenic Antibody, Ramucirumab, in Advanced, K-ras Wild-type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy
CSMC Protocol #: 2011-05
Other Sponsoring Protocol #: ECOG 7208
Principal Investigator: Jeffrey Silberberg, MD
Study Coordinator: Jennifer Beukers, RN 732-303-5047
Description: To determine the effect of Ramucirumab in combination with irinotecan and cetuximab on toxicity, progression-free survival, and overall survival of patients.
Eligibility Criteria: Patients at least 18 years of age with metastatic or advanced colorectal cancer who have progressed following first-line treatment with oxaliplatin-based fluoropyrimidine-containing chemotherapy and bevacizumab, are eligible for the study. Patients with active infections, heart disease, bleeding disorder, other cancers requiring treatment within the last 3 years, intestinal obstruction, or inflammatory bowel disease, or who are pregnant are not eligible to be in the study.
Lung Cancer
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 732-303-5047
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: LUX-Lung EAP US; An open label expanded access program of afatinib (BIBW 2992) for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s)
CSMC Protocol #: 2012-13
Other Sponsoring Protocol #: Boehringer-Ingelheim 2012-13
Principal Investigator: Jeffrey Silberberg, MD
Description: The purpose of this study is to provide early access and to evaluate the safety, tolerability and effectiveness of afatinib for patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR mutation(s).
Eligibility Criteria: Patients at least 18 years of age with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), who test positive for the Epidermal Growth Factor Receptor (EGFR) mutation, have adequate organ function are eligible for the study. Patients who have had hormonal anti-cancer treatment within 2 weeks of the start of the trial, radiation treatments within 14 days of drug administration, or have had major surgery within 4 weeks of the start of the trial are not eligible to be in the study.
Prostate Cancer
1) 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 #: 2009-20
Other Sponsoring Protocol #: RTOG 0815
Principal Investigator: H. Tsai, MD and Edward Soffen, MD
Study Coordinator: Jennifer Beukers, RN 732-303-5047
Description: The purpose of this study is to compare the effects of dose-escalated radiation therapy with or without hormone therapy on prostate cancer.
Eligibility Criteria: Males over the age of 18 diagnosed with adenocarcinoma of the prostate, at intermediate risk for recurrence, within 6 months prior to registration or previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate risk disease are eligible for enrollment. Patients not eligible for this trial if their Gleason Score is 8 or higher; OR have a PSA greater than 20; OR Clinical Stage greater than or equal to T3; OR have a prior invasive malignancy unless disease free for a minimum of 5 years; OR have had prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer.
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 732-303-5047
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: Evaluation of SpaceOAR™ System when used to Create Space Between the Rectum and Prostate in Men Undergoing Image Guided – Intensity Modulated Radiation Therapy (IG-IMRT) for Localized Stage T1-T2 Prostate Cancer: A Randomized, Multicenter, Parallel Arm Controlled Clinical Study
CSMC Protocol #: 2012-13
Other Sponsoring Protocol #: AGX-11-001-US
Principal Investigator: Edward M. Soffen, MD
Description: The purpose of the SpaceOAR System is to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum.
Eligibility Criteria: Eligible patients must have pathologically confirmed invasive adenocarcinoma of the prostate, with a clinical stage T1 or T2 with a Gleason Score ≤ 7, PSA ≤ 20 ng/mL, and must be planning to undergo IMRT. Patients who have had any prior invasive malignancy; a history of prostatectomy, transurethral prostate surgery if performed within 1 year prior to screening, other local prostate cancer therapy (e.g., cryotherapy or brachytherapy), or previous pelvic irradiationare; or who have a history of prior pelvic surgery requiring low anterior or abdominoperineal resections or rectal surgery are not eligible to be in the study.
Multiple Sclerosis
1) Study Title: JCV Antibody Program in Patients with Relapsing MS Receiving or Considering Treatment with Tysabri®: STRATIFY-2
CSMC Protocol #: 2010-10
Other Sponsoring Protocol #: Biogen 101JC402 STRATIFY-2
Principal Investigator: A. Katz, MD
Study Coordinator: Heba Darwish, MPH 732-637-6353
Description: The purpose of STRATIFY-2 is to better understand whether antibodies to JCV may be used to predict whether a patient is at higher or lower risk for developing PML. Tysabri is associated with an increased risk of Progressive Multifocal Leukoencephalopathy (PML) and JC is the virus that is linked to PML. Biogen Idec has developed a blood test that measures antibodies to JCV. Antibodies are produced by the body’s immune system when it detects foreign substances.
Eligibility Criteria: You are eligible to participate in this study if you are currently receiving Tysabri treatment for your relapsing MS or you are considering treatment with Tysabri.
2) Study Title: A 96-Week, prospective, multicenter, randomized, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis
CSMC Protocol #: 2010-18
Other Sponsoring Protocol #: AB Science AB07002
Principal Investigator: A. Katz, MD
Study Coordinator: Heba Darwish, MPH 732-637-6353
Description: The purpose of this study is to compare the effect and safety of a trial drug, masitinib, to a placebo given during 96 weeks to patients who have primary progressive or relapse-free, secondary progressive multiple sclerosis. It has become clear over the past years that some human diseases are the result of a defect in cell signals. Masitinib is a drug that blocks the activity of enzymes that play a basic role in passing signals between cells. Reducing the activity of these enzymes combined with decreased mast cells has been seen in the study of diseases.
Eligibility Criteria: Males or females aged 18 or older with primary progressive or relapse-free secondary progressive multiple sclerosis, or primary progressive or secondary progressive multiple sclerosis without relapse within 2 years before inclusion with normal organ function. Patients are not eligible to be in the study if they had a major surgery within 2 weeks of study entry, OR a life expectancy of less than 6 months, OR a history of primary malignancy less than 5 years, OR a cardiac disorder.
3) Study Title: A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients (STRIVE)
CSMC Protocol #: 2012-11
Other Sponsoring Protocol #: Biogen 101MS407
Principal Investigator: A. Katz, MD
Study Coordinator: Heba Darwish, MPH 732-637-6353
Description: The purpose of the study is to find out if there are any assessments that might predict whether or not patients receiving Tysabri will remain free of disease (that is, without relapses, worsened disability, and/or lesions on brain magnetic imaging [MRI] scans) and how effective Tysabri is at keeping patients who are in the early stages of RRMS free of disease.
Eligibility Criteria: Males or females 18 to 45 years of age old diagnosed with relapsing multiple sclerosis in less than 3 years. Patients are not eligible to be in the study if they had any prior treatment with Tysabri or they are Anti-JCV antibody positive, have active malignancies or had a history of immunosuppressive therapy.
4) Study Title: A 12-month, randomized, rater- and dose-blinded study to compare the efficacy and safety of fingolimod 0.25 mg and 0.5 mg administered orally once daily with glatiramer acetate 20 mg administered subcutaneously once daily in patients with relapsing-remitting multiple sclerosis.
CSMC Protocol #: 2013-02
Other Sponsoring Protocol #: Novartis CFTY720D2312
Principal Investigator: A. Katz, MD
Study Coordinator: Heba Darwish, MPH 732-637-6353
Description: The main purpose of this study is to compare 2 doses of fingolimod (0.25 mg and 0.5 mg) with glatiramer acetate 20 mg and to evaluate the effectiveness and safety of fingolimod 0.25 mg for people with relapsing-remitting multiple sclerosis.
Eligibility Criteria: Male and female patients 18 to 65 years of age diagnosed with relapsing multiple sclerosis relapse free within 30 days of randomization. Patients are not eligible to be in the study if they had a history of malignancy, HIV positive.
Renal Cancer
1) Study Title: EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study
CSMC Protocol #: 2011-12
Other Sponsoring Protocol #: SWOG S0931
Principal Investigator: Jeffrey Silberberg, MD
Study Coordinator: Jennifer Beukers, RN 732-303-5047
Description: To compare recurrence-free survival in patients with kidney cancer randomly assigned to one year of everolimus versus one year of placebo after nephrectomy or partial nephrectomy.
Eligibility Criteria: Patients at least 18 years of age with kidney cancer, who have had a nephrectomy or partial nephrectomy within 84 days of enrollment, are eligible for the study. Patients with grade II/IV heart disease, underlying pulmonary disease, liver disease, HIV, prior anti-cancer treatment for renal cell carcinoma, gastro-intestinal disorders that would prevent taking oral medication, or who are pregnant or nursing are not eligible to be in the study.