A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379) Save

Date Added
October 8th, 2018
PRO Number
Pro00082422
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for patients who have been diagnosed with a neuroblastoma (NBL). The purpose of this study is to find out if we can improve the treatment for subjects with high-risk NBL by adding the experimental drug 131I-MIBG or the experimental drug Crizotinib to recommended therapy. The secondary purpose is to find out if we can reduce the number of stem cell transplants from two to one if we give the experimental drug 131I-MIBG during Induction, and use different drugs as part of the transplant chemotherapy given prior to stem cell infusion during Consolidation. Participants can expect to be in this study for up to 2 years. Researchers would like to continue to follow participants health for up to 10 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors Save

Date Added
October 8th, 2018
PRO Number
Pro00082427
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Germ Cell Tumors. The purpose of this study is to evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients (ages 0- 50 years) with Stage I (low risk) malignant germ cell tumors, and at least 98% for patients with ovarian pure immature teratoma. The drugs used in this study are carboplatin and cisplatin. Participants will be followed for up to 10 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones Save

Date Added
October 3rd, 2018
PRO Number
Pro00082665
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients who have been diagnosed with a form of Acute Lymphoblastic Leukemia (ALL) called Philadelphia chromosome positive (Ph+) ALL. The purpose of this study is to compare disease free survival (DFS) of Standard Risk (SR) pediatric Ph+ ALL treated with continuous imatinib combined with either a high-risk COG ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone. A drug called imatinib in combination with chemotherapy will be given. Participants can expect to be in this study for up to 2 years and their health followed for up to 10 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A STEPPED-CARE TELEHEALTH APPROACH TO TREAT DISTRESS IN RURAL CANCER SURVIVORS Save

Date Added
October 2nd, 2018
PRO Number
Pro00082222
Researcher
Chanita Hughes-halbert
Keywords
Cancer, Depression
Summary

This study is for men and women with a history of cancer and distress (i.e. anxiety and/or depressive symptoms). The purpose of this research study is to determine the feasibility and effects of a telephone-based, stepped-care mental health intervention (which means that the level of intervention is based on the severity of symptoms) versus enhanced usual care for post-treatment cancer survivors with moderate or severe levels of emotional distress (anxiety and/or depressive symptoms).

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

A PHASE 2, OPEN-LABEL, RANDOMIZED STUDY OF ALT-803, A FUSION PROTEIN ACTIVATOR OF NATURAL KILLER AND T CELLS, IN COMBINATION WITH PEMBROLIZUMAB VS PEMBROLIZUMAB ALONE AS FIRST-LINE TREATMENT FOR PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) Save

Date Added
September 25th, 2018
PRO Number
Pro00080330
Researcher
John Wrangle
Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with metastatic, non-small cell lung cancer (NSCLC), have not received any prior chemotherapy for metastatic disease, and are eligible to receive pembrolizumab, a FDA approved standard therapy for NSCLC. The investigational drug in this study is ALT-803. In this research study, participants will be selected by chance to receive either the study drug ALT-803 in combination with pembrolizumab or will receive pembrolizumab alone. The purpose of this research study is to test the effectiveness of the study drug, ALT-803, in combination with pembrolizumab compared to pembrolizumab alone. Participants can expect to be in this study for 24 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer Save

Date Added
September 25th, 2018
PRO Number
Pro00080886
Researcher
Michael Lilly
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Prostate
Summary

The purpose of this research study is to determine the effectiveness and safety of niraparib used in combination with JNJ-63723283 in the treatment of subjects with advanced prostate cancer. The study medication, niraparib and JNJ-63723283 are given in cycles, with each cycle lasting 28 days. You will continue study medication for as long as your disease does not appear to be getting worse based on assessments by your doctor.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase I/II Study of Pomalidomide, Dexamethasone and Ixazomib VS. Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Relapsing on Lenalidomide as Part of First Line Therapy Save

Date Added
September 20th, 2018
PRO Number
Pro00082054
Researcher
Tondre Buck
Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to compare the effects, good and/or bad, of the study drugs pomalidomide, ixazomib and dexamethasone, or the study drugs pomalidomide and dexamethasone, on participants and their multiple myeloma to find out which is better. In this study, participants will get either the study drugs pomalidomide, ixazomib and dexamethasone or the study drugs pomalidomide and dexamethasone. If participants are assigned to the study drugs pomalidomide and dexamethasone and experience progression of their multiple myeloma, they will have the option to receive the study drug ixazomib in combination with the study drugs pomalidomide and dexamethasone.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer Treated with Curative Intent Save

Date Added
September 6th, 2018
PRO Number
Pro00081552
Researcher
Carolyn Britten
Keywords
Cancer, Cancer/Gastrointestinal
Summary

Patients will complete questionnaires at 5 time points over 24 months (within 60 days of diagnosis, then at 3, 6, 12 and 24 months after diagnosis). Surveys can be done either on paper or online. It is estimated that it will take 45-60 minutes to complete the first questionnaire and 20-30 minutes to complete the 3, 6, 12 and 24 month questionnaires. Information requested will be about the patient's finances and employment, as well as basic demographic information which will be obtained from the patient's medical records. Patients will be asked to provide their contact information to the ECOG-ACRIN Outcomes and Economics Assessment Unit at Brown University, which will administer the surveys.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined with Intravesical BCG in Participants with BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer Save

Date Added
August 28th, 2018
PRO Number
Pro00080821
Researcher
Theodore Gourdin
Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies
Summary

The purpose of this study is to evaluate Nivolumab or Nivolumab plus Experimental Medication BMS-986205 with or without BCG (bacillus Calumette-Guerinin) BCG-Unresponsive non-muscle invasive Bladder Cancer. You will be randomized (assigned by chance) to receive treatment in either Arm A, Arm B, Arm C or Arm D. Arm A is Nivolumab alone, Arm B is Nivolumab and BCG (Bacille Calmette Guerin), Arm C is Nivolumab with IDO1 Inhibitor (BMS-986205), and Arm D is Nivolumab with IDO1 Inhibitor (BMS-986205) and BCG . An IDO1 inhibitor (such as BMS-986205) is designed to block the function of a protein (called an enzyme), called IDO1 within the body.Blocking the IDO pathway may help the immune system to fight abnormal cancer cells in the body.This is an open label study which means both you and your doctor will know which treatment you are receiving. You will take your assigned study medication as assigned based on your treatment arm for 52 weeks

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist) Save

Date Added
August 21st, 2018
PRO Number
Pro00075705
Researcher
Thomas Keane
Keywords
Cancer, Cancer/Genitourinary, Cardiovascular, Drug Studies, Prostate
Summary

The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in patients with prostate cancer and cardiovascular disease.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

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