A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients Save

Date Added
January 7th, 2019
PRO Number
Pro00083234
Researcher
Jacqueline Kraveka

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Profiles_link
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with a pediatric brain tumor called medulloblastoma. The purpose of this study is to find out if a reduced dose of radiation to the whole brain and spine and less chemotherapy can be given to children and young adults with WNT subtype medulloblastoma without increasing the risk of the tumor coming back. Participants can expect to be in this study for about one year, and then followed for up to 10 years.

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

A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors Save

Date Added
November 21st, 2018
PRO Number
Pro00083280
Researcher
Jacqueline Kraveka

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Profiles_link
Keywords
Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with a germ cell tumor. The purpose of this study is to compare the overall survival in patients treated with conventional-dose chemotherapy using the TIP regimen with high-dose chemotherapy (HDCT) plus ASCT using the TI-CE regimen as initial salvage treatment of patients with relapsed or refractory GCT. Participants can expect to be in this study for 12 to 16 weeks, depending on what group they are randomized to. Participants will continue to be followed for up to 5 years.

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

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

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

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Profiles_link
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

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Profiles_link
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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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 Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS) Save

Date Added
April 17th, 2018
PRO Number
Pro00076211
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Sarcoma, Pediatrics
Summary

This study is for patients that have been diagnosed with rhabdomyosarcoma (RMS). The investigational drug in this study is Temsirolimus. The purpose of this study is to find out if we can improve the treatment for subjects with intermediate risk RMS by adding temsirolimus to VAC/IV therapy. Participants can expect to be in this study for approximately 1 year and would like to continue to follow-up with the patient every year for about 10 years.

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

List of Studies


Profiles_link
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

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