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 inelligible.

 

2) Study Title: A randomized study to prevent Lymphedema in women treated for breast cancer

CSMC Protocol #: 2009-17

Other Sponsoring Protocol #: CALGB 70305
Principal Investigator: Jarrod Kaufman, M.D., Jennifer Beukers, RN, Marinelle Japzon, PT, Elissa Fiorito, PT
Study Coordinator: Jennifer Beukers, RN

Description: The determine the effects of an education program on whether or not a woman gets Lymphedema and the quality of life in women treated for breast cancer.

Eligibility Criteria: Women, age 18 or older, newly diagnosed with Stage I-III cancer of the breast, with no prior history of breast cancer. Patients with other invasive cancers who have completed treatment and are 5 years post-diagnosis are eligible. Patients who have only surgery are eligible. Patients scheduled for radiation or chemotherapy must have pre-surgery measurements. Women are not eligible if they already have Lymphedema, are homebound, not able to walk independently, and are unable to participate in a mild exercise program. Women who participate in the study must be willing to complete the 18 months of the study.

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

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.

 

 

CSMC Protocol #: 2011-04

Other Sponsoring Protocol #: ECOG 2208
Principal Investigator: Jeffrey Silberberg, MD
Study Coordinator: Jennifer Beukers, RN 732-303-5047

 

Description: To determine the effects cixutumumab (IMC-A12) has on esophagus cancer when combined with the chemotherapy drug, paclitaxel.

 

Eligibility Criteria: Patients at least 18 years of age with metastatic disease of the esophagus or gastroesophageal junction, who have received one line of systemic or radiation treatment and progressed after treatment, with a life expectancy of at least 12 weeks are eligible for the study. Patients who have poorly controlled diabetes mellitus, had major surgery, who are on hormonal therapy, have received chemotherapy within 4 weeks prior to entering the study, or who are pregnant are not eligible to be in the study.

 

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.

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.

 

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

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.

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.

 

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.

 

 

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: 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®.

 

CSMC Protocol #: 2011-12

Other Sponsoring Protocol #: SWOG

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.