Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or Durvalumab in Combination with Tremelimumab in Pediatric Patients with Advanced Solid Tumors and Hematological Malignancies Save

Date Added
July 9th, 2019
PRO Number
Pro00087746
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for pediatric patients that have been diagnosed with advanced solid tumors and hematological malignancies that have stopped responding to standard therapy. The investigational drugs in this study are durvalumab and tremelimumab. The purpose of this research study to find out if the study drugs called durvalumab and tremelimumab will work and be safe for the treatment of advanced cancer in children. Participants can expect to be on this study for up to 6 years.

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

A Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Germ Cell Tumors Save

Date Added
July 3rd, 2019
PRO Number
Pro00089975
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed metastatic germ cell tumors. This study will compare the standard chemotherapy regimen with an accelerated chemotherapy regimen using the same drugs to see if the accelerated chemotherapy regimen is beneficial but not more toxic than the standard chemotherapy regimen. The accelerated chemotherapy is experimental. Participants can expect to be on study for about 3 months and 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

Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of Osteosarcoma Save

Date Added
July 3rd, 2019
PRO Number
Pro00090359
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients who have been diagnosed with osteosarcoma and were once treated with a chemotherapy drug called cisplatin with or without ifosafamide. The purpose of this study is to look at potential effects on fertility in male osteosarcoma survivors treated with cisplatin with or without ifosfamide compared to male controls without a history of cancer. Participants can expect to be on this study for up 3 months.

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

A Phase 1b, Multicenter, double blind randomized controlled dose escalating trial of fentanyl vs. fentanyl + dexmedetomidine as the initial regimen for maintenance of sedation in mechanically-ventilated, critically ill children Save

Date Added
June 20th, 2019
PRO Number
Pro00089667
Researcher
John Costello

List of Studies

Silhouette
Keywords
Pediatrics
Summary

We are asking children to be in the study because he/she needs pain
medicine and also needs a breathing machine while in the intensive care unit. Children who are on a breathing machine in the intensive care unit are usually given a drug called fentanyl to treat pain. But fentanyl can be addictive and children can have withdrawal effects when the medicine is stopped. This
study will test whether adding another medication, dexmedetomidine, will reduce the amount of fentanyl needed while children are on the breathing machine. Every child in the study will get regular pain medicine. They will also receive either the study drug or the placebo (fluid with no drugs in it). This means not all children will get the study drug. Approximately 75% of the participants will receive
the study drug and 25% will receive the placebo.
Children will receive either fentanyl with the study drug (dexmedetomidine) or fentanyl with saline placebo for up to 7 days. The study doctors will follow each participant for a total of up to 28 days.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue Save

Date Added
June 12th, 2019
PRO Number
Pro00089045
Researcher
Sandeepkumar Kuril

List of Studies

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Keywords
Cancer, Pediatrics
Summary

This study is for participants who have been diagnosed with a brain tumor called either a medulloblastoma or Central Nervous System embryonal tumors of the brain or spinal cord. The investigational drugs used in this study are thiotepa, etoposide and carboplatin. The purpose of this study is to test tumor for biologic markers that will help us know how to best treat each subject on this treatment study. Participants can expect to be on this study for up to 5 years and followed until end of study or disease progression.

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

Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study) Save

Date Added
May 15th, 2019
PRO Number
Pro00081406
Researcher
Michelle Hudspeth

List of Studies


Profiles_link
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Epstein-Barr Virus associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD). The investigational drug in this study is tabelecleucel. Tabelecleucel is a product containing special immune allogeneic cells, called EBV-Cytotoxic T Lymphocytes (EBV-CTLs), that are made in the laboratory starting with cells from a healthy person who is immune to EBV. The purpose of this study is to test how well tabelecleucel works to treat EBV-PTLD following SOT in patients who have not responded to rituximab or rituximab plus chemotherapy treatment and to see what side effects happen. Your participation will help us to understand more about tabelecleucel. In the first 12-month period, participants will be asked to come to the clinic for an estimated 11 to 19 study visits and a minimum of 2 scans, depending on the number of cycles of treatment they are given. After treatment is done, participants will enter into the follow-up phase, and will continue to come into the clinic for scheduled check-ups for up to 24 months after the first dose of tabelecleucel was given. Participant information on the status of their disease and any new treatment will be collected for up to an additional 3 years. Participants can expect to be in this study for up to five years total.

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

Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab (MATCH Study) Save

Date Added
May 8th, 2019
PRO Number
Pro00081745
Researcher
Michelle Hudspeth

List of Studies


Profiles_link
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with EBV-associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD). The investigational drug in this study is tabelecleucel. Tabelecleucel is a product containing special immune allogeneic cells, called EBV-Cytotoxic T Lymphocytes (EBV-CTLs), that are made in the laboratory starting with cells from a healthy person who is immune to EBV. Tabelecleucel will be given by vein as an injection. The purpose of this study is to test how well ATA129 works to treat EBV-PTLD following failure of rituximab in patients who have had an alloHCT and to see what side effects happen. Participation will help us to understand more about ATA129. In the first 12-month period, participants will be asked to come to the clinic for an estimated 11 to 19 study visits and a minimum of 2 scans, depending on the number of cycles of treatment they are given. After treatment is done, participants will enter into the follow-up phase, and will continue to come into the clinic for scheduled check-ups for up to 24 months after the first dose of tabelecleucel was given. Participant information on the status of their disease and any new treatment will be collected for up to an additional 3 years. Participants can expect to be in this study for up to five years total.

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

Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation (ACES) PBMTC SUP1701 Save

Date Added
May 7th, 2019
PRO Number
Pro00084735
Researcher
Michelle Hudspeth

List of Studies


Profiles_link
Keywords
Cancer, Pediatrics, Transplant
Summary

This study is for patients that have had a Hematopoietic Stem Cell Transplant (HSCT) and still have persistent Cytomegalovirus (CMV), adenovirus and/or Epstein-Barr Virus (EBV) infection; or have a Primary Immunodeficiency Disorder (PID) with one or more viral infections that persist. The primary purpose of the study is to evaluate whether most closely HLA-matched multivirus-specific T cell lines obtained from a bank of allogeneic virus-specific T cell lines (VSTs) have antiviral activity against three viruses: EBV, CMV and adenovirus. Participants can expect to be on this study for about 12 months.

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

eACT (epilepsy: Adherence in children and technology) Save

Date Added
May 4th, 2019
PRO Number
Pro00087259
Researcher
Janelle Wagner

List of Studies

Silhouette
Keywords
Children's Health, Epilepsy, Pediatrics
Summary

The aim of this multi-site study is to evaluate the effectiveness of mHealth intervention strategies for improving anti-epileptic drug adherence in caregivers of young children with epilepsy. A 2-month baseline period will be followed by two stages. In Stage 1 (3-months), caregivers will received either 1) a mHealth education module and automated digital reminders or 2) the mHealth education module, automated digital reminders, and individualized adherence feedback based. In Stage 2 (2-months), caregivers will either receive 1) continued individualized adherence feedback or 2) individualized adherence feedback and a mHealth problem-solving module. The primary outcome is electronically-monitored adherence. Secondary outcomes include seizure severity/frequency, quality of life and healthcare utilization.

Institution
MUSC
Recruitment Contact
Millie Griffin
843-792-4653
grifm@musc.edu

A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Axitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups Save

Date Added
April 29th, 2019
PRO Number
Pro00088789
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed kidney cancer called TFE/Translocation Renal Cell Carcinoma (tRCC). The investigational drugs in this study are axitinib and nivolumab. Both axitinib and nivolumab have been approved by the FDA for treating RCC. However, using these 2 drugs together is considered experimental. The purpose of this study is to find out what effects, good and/or bad, axitinib and nivolumab have on subjects with tRCC when the drugs are given alone or in combination. Participants can expect to be on this study for about to years and followed for up to 5 years.

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

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