Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)

Date Added
April 12th, 2021
PRO Number
Pro00109105
Researcher
Sarah Marrison

List of Studies


Keywords
Cancer, Pain
Summary

The study is being done to find out if this approach (8 sessions of the Internet-based program with education) is better or worse than the usual approach plus education only for cancer-related pain. The usual approach is defined as care most people get for cancer-related pain.

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

Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO

Date Added
March 3rd, 2021
PRO Number
Pro00108563
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients that have been diagnosed with non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using pembrolizumab plus the usual treatment. The investigational drug in this study is pembrolizumab. This drug, pembrolizumab is already approved by the FDA for use in patients with more advanced lung cancer. Participants can expect to be on treatment for up to a year. Participants will be followed for up to 10 years after completion of treatment.

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

A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma

Date Added
February 23rd, 2021
PRO Number
Pro00105358
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with a relapsed, progressive and/or refractory subtype of B-cell non-Hodgkin lymphoma (diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, marginal zone lymphoma, small lymphocytic lymphoma or follicular lymphoma). The investigational drug that will be tested is called GEN3013 (DuoBody®-CD3xCD20). The purpose of the trial is to investigate the safety, tolerability and efficacy of GEN3013 in subjects with different subtypes of B-cell non-Hodgkin lymphoma (referred to as B-cell NHL). Participants can expect to be in this study for 36 weeks of treatment, plus follow up until the disease progresses.

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

67Cu-SARTATE Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma: A Multi-center, Dose-escalation, Open-label, Non-randomized, Phase 1-2a Theranostic Clinical Trial

Date Added
February 9th, 2021
PRO Number
Pro00105726
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for participants that have been diagnosed with a high-risk neuroblastoma that cannot be treated or did not improve with existing therapies, or the cancer came back after treatment with existing therapies. This study involves investigational drugs called 64Cu-SARTATE and 67Cu-SARTATE. The investigational drugs will be given as an IV injection. The study is divided into 2 parts: The Dose Escalation Phase and the Cohort Expansion Phase. The phase that participants will enroll to will depend on when they enter the study. The age range for participants is from 12 months to 25 years. Participants can expect to be in this study for approximately 14 months. Then followed by remote or virtual visits every 6 months for up to 36 months (3 years) after the initial dose of study therapy drug 67Cu-SARTATE.

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

A Phase 2, Open-Label, Multi-Center Study of PDS0101 (R-DOTAP [Versamune®] + HPVmix) and Pembrolizumab (KEYTRUDA®) Combination Immunotherapy in Subjects with Recurrent and/or Metastatic Head and Neck Cancer and High-Risk Human Papillomavirus-16 (HPV16) Infection

Date Added
February 9th, 2021
PRO Number
Pro00101695
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with Head and Neck Cancer that spread to sites distant from the head and neck region (metastatic) or for cancer that returned or got worse after being treated (recurrent), and test positive for High-risk Human Papillomavirus-16 (HPV16) Infection.

The investigational vaccine in this study is called PDS0101. "Investigational" means the study vaccine being tested has not been approved by the United States Food and Drug Administration (FDA). The purpose of this research is to find out if the combination of the investigational vaccine, given by subcutaneous (beneath the skin) injection and the standard of care, Pembrolizumab (KEYTRUDA®), given by IV, are effective and safe. The PDS0101 vaccine designed to boost the body's immune response against HPV 16.Participants can expect to receive treatment for about 2 years. Each person who agrees to take part in the study will be asked to come in for a minimum of 18 cycles and a maximum of 35 cycles.

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

A Phase 2, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)

Date Added
February 1st, 2021
PRO Number
Pro00101229
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with head and neck squamous cell carcinoma (HNSCC) that has returned (recurrent) or spread after previous treatment (metastatic). The investigational drug in this study is lenvatinib. The study will also use lenvatinib in combination with pembrolizumab, which is also experimental. The purposes of this study are to: test the safety of the study drugs, lenvatinib alone, pembro and lenvatinib together, and standard chemotherapies alone in the treatment of HNSCC; see how well the combination of pembro and lenvatinib works, compared to standard chemotherapies; and see if participants who get pembro and lenvatinib live longer than those who are treated with standard chemotherapies. Participants can expect to be on this study for about 48 months.

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

Phase 1/2, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ALVR106 in Addition to Standard of Care for the Treatment of High-Risk Patients with Respiratory Viral Infections After Hematopoietic Stem Cell or Solid Organ Transplant

Date Added
January 12th, 2021
PRO Number
Pro00103083
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with a respiratory viral infection, like respiratory syncytial virus (RSV), influenza, human metapneumovirus, and/or parainfluenza virus, after a hematopoietic cell transplant. The investigational drug in this study is ALVR106. The purpose of this study is to determine if ALVR106 is safe and to determine the best dose (amount) for treating respiratory infections. Participants can expect to be in this study for approximately 1 year.

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

A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Date Added
December 22nd, 2020
PRO Number
Pro00106138
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have newly diagnosed High-Risk B-ALL, Risk-Adapted Post-Induction therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy. The treatment involves medicine called chemotherapy, which fights cancer. Some patients may also need radiation therapy depending on whether the cancer has spread to the brain and spinal fluid, or the testes for males. The investigational drug on this study is inotuzumab ozogamicin. Participants can expect to be on this study for a little over 2 years and followed for up to 10 years.

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

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors

Date Added
November 24th, 2020
PRO Number
Pro00105157
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with advanced or resistant skin cancer (melanoma), non-melanoma skin cancer (NMSC), non-small cell lung cancer (NSCLC), certain types of solid tumors, or bladder cancer (UBC). The investigational drug in this study is RP1. RP1 is a herpes simplex virus (a microscopic life form commonly known as the "cold sore virus") that has been genetically changed to grow in and destroy cancer cells. This treatment will be injected directly into tumors. The purpose of this study is to test the safety and how well RP1 works when it is injected into certain types of solid tumors in combination with another cancer drug, called nivolumab. Participants can expect to be in this study for about 2 to 3 years.

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

Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Date Added
November 19th, 2020
PRO Number
Pro00105634
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT). The treatment involves cancer fighting medicine called chemotherapy plus radiation therapy and/or surgery. Participants can expect to be on this study for up to 10 months and be followed by the treatment team 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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