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

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

Silhouette
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

Phase 1/2 Study of ASP2215 (Gilteritinib) Combined with Atezolizumab in Patients with Relapsed or Treatment Refractory FLT3 Mutated Acute Myeloid Leukemia (AML) Save

Date Added
June 11th, 2019
PRO Number
Pro00088311
Researcher
Robert Stuart

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Leukemia, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with AML, with a mutation, or change, in the FLT3 gene. The investigational drug in this study is gilteritinib (ASP2215). The purpose of this research study is see if a medicine called gilteritinib (ASP2215) given in combination with atezolizumab is both effective and safe as a treatment for AML patients with a mutation, or change, in the FLT3 gene. Participants can expect to be in this study for roughly 2 years.

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

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large b-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release Save

Date Added
May 28th, 2019
PRO Number
Pro00088512
Researcher
Brian Hess

List of Studies

Silhouette
Keywords
Cancer, Cancer/Leukemia, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with B-cell acute lymphoblastic leukemia (ALL) or large B-cell lymphomas. The investigational drug in this study is CTL019 (Tisagenlecleucel). The purpose of this study is to provide the investigational drug as a possible cancer treatment that would otherwise be unavailable. Patients can expect to be in this study for up to 3 months and in follow up for 15 years.

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

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826) Save

Date Added
May 20th, 2019
PRO Number
Pro00082686
Researcher
Whitney Graybill

List of Studies

Silhouette
Keywords
Cancer, Cancer/Gynecological, Women's Health
Summary

This clinical trial hopes to test the safety and effectiveness of the study drug, pembrolizumab (MK-3475), in combination with chemotherapy, and if this combination will improve survival in women with persistent, recurrent, or metastatic cervical cancer. You may be able to join this study if you are a female at least 18 years of age with persistent, recurrent, or metastatic cervical cancer and have not been treated with systemic chemotherapy, other than chemotherapy that was received with radiation. Participation will be based on specific criteria.
The study duration is estimated at about 2 years, and in some cases may be longer.

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

A Phase II Randomized Study of Adjuvant Versus NeoAdjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High-Risk Melanoma Save

Date Added
May 7th, 2019
PRO Number
Pro00088579
Researcher
Andrea Abbott

List of Studies

Silhouette
Keywords
Cancer, Cancer/Skin
Summary

This study is for participants that have been diagnosed with clinically detectable stage III-IV high-risk Melanoma. The investigational drug in this study is pembrolizumab. The purpose of this study is to compare outcomes of receiving the study drug either before and after or only after surgery for your type of cancer. Participants can expect to be followed for up to 10 years after they register to the study.

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

A Multicenter, Randomized Trial of Photodynamic Therapy versus Argon Plasma Coagulation for Lung Cancer with Endobronchial Obstruction Save

Date Added
April 29th, 2019
PRO Number
Pro00081628
Researcher
Nicholas Pastis

List of Studies


Profiles_link
Keywords
Cancer, Lung, Pulmonary
Summary

Other than Nd:YAG laser, no other comparative studies of thermal ablative therapies with PDT for malignant airway obstruction have been performed. Little has been published about need for additional therapies and changes in quality of life following airway de-obstruction procedures in a randomized fashion comparing different modalities. The aim of this multicenter, prospective, randomized clinical study is to evaluate the efficacy of PDT vs APC.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@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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