Prospective Non-Interventional Study in Patients with Locally Advanced or Metastatic TRK Fusion Cancer Treated with Larotrectinib

Date Added
September 17th, 2020
PRO Number
Pro00090298
Researcher
Jacqueline Kraveka

List of Studies

Keywords
Adolescents, Cancer, Pediatrics
Summary

This is an observational study, which means that only information is collected on treatment, examinations or diagnostic tests which are a part of the routine standard of care. The participant is being asked to volunteer because they have been diagnosed with locally advanced or metastatic TRK fusion cancer treated with larotrectinib. The purpose of this study is to learn more about the safety profile and the effectiveness of VITRAKVI® under routine practice conditions.
Participants will be followed for a minimum of 5 years from the time they agree to participate in the study.

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

A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG)

Date Added
September 2nd, 2020
PRO Number
Pro00102404
Researcher
Jacqueline Kraveka

List of Studies

Keywords
Brain, Cancer, Pediatrics
Summary

This study is for patients that have been newly diagnosed with BRAF v600-Mutant High-Grade Glioma (HGG). The overall goal of this study is to see if using two drugs called dabrafenib and trametinib after radiation treatment will be better than treatments used in the past in helping to get rid of or shrink HGG. The treatment involves cancer fighting medicines plus radiation. The treatment on this study takes a little over 2 years. It is divided into 2 phases of therapy.

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

A Phase 2 Study of Veliparib (ABT-888) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients With Newly Diagnosed High-Grade Glioma (HGG) Without H3 K27M or BRAFV600 Mutations

Date Added
April 24th, 2020
PRO Number
Pro00099128
Researcher
Jacqueline Kraveka

List of Studies

Keywords
Brain, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with newly diagnosed High-Grade Glioma (HGG). The investigational drug in this study is veliparib. The purpose of this study is to see if veliparib given with radiation therapy followed by veliparib with temozolomide given as maintenance therapy works better than treatments that have been tried in the past. Participants can expect to be in this study for about 1 year and 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 Trial Investigating Blinatumomab ( NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphoma (B-LLy)

Date Added
January 22nd, 2020
PRO Number
Pro00095606
Researcher
Jacqueline Kraveka

List of Studies

Keywords
Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lymphoblastic Lymphoma (B-LLy). The investigational drug used is Blinatumomab. The purpose of this study is to determine in a randomized manner if the addition of 2 cycles of blinatumomab to standard therapy improves disease-free survival (DFS) in patients with SR B-ALL and higher risk features (SR-High), and patients with standard-risk average (SR-Avg) B-ALL who are negative for minimal residual disease (MRD) by flow cytometry but have detectable or indeterminate MRD as measured by high-throughput sequencing (HTS) at end of Induction (EOI). Participants can expect to receive treatment on this study for about 2 years. After treatment, participants will be followed-up with every year for about 10 years.

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

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

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

List of Studies

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

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

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

List of Studies

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

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

List of Studies

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

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

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

List of Studies

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

Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial

Date Added
March 26th, 2019
PRO Number
Pro00087159
Researcher
Jacqueline Kraveka

List of Studies

Keywords
Cancer, Heart, Pediatrics
Summary

This study is for patients that are survivors of childhood cancer who received a type of treatment called anthracycline chemotherapy at a young age. The investigational drug in this study is carvedilol. Medications such as carvedilol have been shown to improve heart function and delay the onset of heart failure. However, carvedilol has not been studied in a large group of childhood cancer survivors who received anthracycline chemotherapy. The purpose of this study is to see if a two-year course of carvedilol in childhood cancer survivors to see if it will have the same effects as shown in these prior studies of people with mild heart failure or who were at risk for heart failure. People in this clinical trial are expected to receive treatment on this study for about 2 years.

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

International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis

Date Added
February 5th, 2019
PRO Number
Pro00084129
Researcher
Jacqueline Kraveka

List of Studies

Keywords
Adolescents, Cancer, Pediatrics, Transplant
Summary

This study is for patients that have been diagnosed with multisystem Langerhans cell histiocytosis (LCH). The purpose of this study is to find out if prolonging the treatment and adding a drug called 6-mercaptopurine will be beneficial. Other goals include fining out if these changes will result in fewer patients having relapse of their LCH, and fewer patients having long term disease related problems. Participants can expect to be in this study for up to 24 months and will be followed on this study fir at least 5 years.

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



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