Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study Save

Date Added
November 19th, 2018
PRO Number
Pro00083220
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Cancer, Cancer/Brain, Pediatrics
Summary

This study is for pediatric patients who have been diagnosed with Brain Tumors. The purpose of this study is to assess the feasibility of a home-based, computerized cognitive training program for patients with pediatric brain tumors who are undergoing cranial radiation therapy (CRT). Participants can expect to receive treatment on this study for about 5 to 9 weeks. Participants will complete additional testing sessions about 6 months after completing the cognitive training program.

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

Phase 2 Trial of XL184 (Cabozantinib), an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors Save

Date Added
November 19th, 2018
PRO Number
Pro00083227
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Cancer, Cancer/Sarcoma, Pediatrics
Summary

This study is for patients that have been diagnosed with one of the following types of cancer: Ewing sarcoma, rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcomas, osteosarcoma, Wilms tumor or another rare tumor. The investigational drug used in this study is called cabozantinib, also known as XL184. The purpose of this study is to determine the response rate of XL184 in children and young adults. Participants in this clinical trial are expected to receive treatment for up to 5 years or until they develop side effects or the tumor worsens. Follow-up exams will be given at 30 days, 6 months and possibly yearly after study treatment completion.

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

Silhouette
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

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

Silhouette
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

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

Silhouette
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

LEAHRN (Late Effects After High-Risk Neuroblastoma) Study Save

Date Added
July 14th, 2018
PRO Number
Pro00080522
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Cancer, Cancer/Brain, Pediatrics
Summary

This study is for patients who have been diagnosed with high-risk neuroblastoma. The purpose of this study is to learn if the treatment you received for your high-risk neuroblastoma has affected your health overtime. Participants can expect to be in this study for up to 12 weeks.

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

A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway?Mutant Acute Lymphoblastic Leukemia Save

Date Added
February 13th, 2018
PRO Number
Pro00071934
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have been diagnosed with High Risk B-Lymphoblastic Leukemia (HR B-ALL). The investigational drug in this study is Ruxolitinib. The purpose of this study is to find out if the study drug, ruxolitinib, in combination with standard HR B-ALL treatment is safe and effective in children, adolescents, and young adults with HR B-ALL. Participants can expect to be in this study for the treatment period of approximately 26 months (females) or 38 months (males) plus the post-treatment follow-up. Subjects are considered on study during the post-treatment follow-up period until the subject is deceased, lost to follow-up, or until the study is completed. Subjects in this study will be followed until all enrolled subjects have been followed for 3 years from Day 1 or are deceased or lost to follow-up.

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

Phase Ib/II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies Save

Date Added
August 22nd, 2017
PRO Number
Pro00066806
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Adolescents, Brain Tumor, Cancer, Cancer/Brain
Summary

This study is for patients that have been diagnosed with Central Nervous System (CNS) Tumors. The investigational drugs in this study are Nivolumab and Ipilimumab. The purpose of this study is to test the effectiveness, safety, and tolerability of Nivolumab when given alone or when combined with Ipilimumab. The duration of patient participation may be more than 3 years. If enrolled in treatment, the exact length of time will depend on the patients response to treatment.

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

A multicenter, multinational, randomized, double-blind, pharmacokinetic and pharmacodynamic (PK/PD) dose-finding study of oral netupitant administered concomitantly with oral palonosetron in pediatric cancer patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy. Save

Date Added
July 25th, 2017
PRO Number
Pro00067181
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for pediatric patients that have been diagnosed with cancer and are receiving chemotherapy. The investigational drugs in this study are netupitant and palonosetron. The purpose of this study is to learn more about how well the combination of oral netupitant and oral palonosetron works in preventing nausea and vomiting associated with chemotherapy in children. Participation in the study will last for a maximum of 31 days, which includes a screening period up to 14 days before randomization (up to 7 days for patients aged less than 2 years), the day of enrollment/randomization, administration of study drugs and chemotherapy (Study Day 1), and the control visits (Study Days 2 to 5).

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

A Two-Part Study of TB-403 in Pediatric Subjects with Relapsed or Refractory Medulloblastoma, Neuroblastoma, Ewing Sarcoma, or Alveolar Rhabdomyosarcoma Save

Date Added
August 9th, 2016
PRO Number
Pro00055732
Researcher
Jacqueline Kraveka

Silhouette
Keywords
Cancer, Pediatrics
Summary

In this study, TB-403 is a reviewed as a possible treatment for relapsed or refractory medulloblastoma (MB), neuroblastoma (NB), Ewing sarcoma (ES), or alveolar rhabdomyosarcoma (ARMS). This study will be conducted to determine the maximum tolerated dose (MTD), or the appropriate dosage, of TB-403. TB-403 will be given during a 28-day dose period in pediatric subjects ages greater than 6 months to less than 18 years of age. Study subjects require a diagnoses and/or history of relapsed or refractory medulloblastoma (MB), neuroblastoma (NB), Ewing sarcoma (ES), or alveolar rhabdomyosarcoma (ARMS). The study will also assess safety and tolerability of TB-403 as well as the preliminary effictiveness for use in pediatric patients with MB, NB, ES or ARMS.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-876-2698
kravekjm@musc.edu

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