A Phase III, Single-Arm Study to Evaluate the Efficacy and Safety of ONCOFID-P-B (paclitaxel-hyaluronic acid conjugate) Administered Intravesically to Patients with BCG-unresponsive Carcinoma in Situ of the Bladder with or without Ta-T1 Papillary Disease

Date Added
October 24th, 2023
PRO Number
Pro00128893
Researcher
Stephen Savage

List of Studies


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

The study is for patients that have been diagnosed with carcinoma in situ of the bladder (localized bladder cancer, also called "non-muscle invasive bladder cancer") with or without Ta-T1 papillary disease (Ta means that the cancer is only in the innermost layer of the bladder lining, T1 means that the cancer has started to grow into the connective tissue beneath the bladder lining). The investigational drug used in this study is ONCOFID-P-B. The main purpose of this study is to understand if the study medicine ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from the standard BCG treatment and are not candidates for radical cystectomy. Participants can expect to be in this study for up to 4 years and will include a screening period of up to 4 weeks followed by up to 33 study visits to the study site.

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

TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients with Non-Small Cell Lung Cancer (NSCLC)

Date Added
September 27th, 2023
PRO Number
Pro00129366
Researcher
Christopher Gilbert

List of Studies

Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

The purpose of this study is to identify whether investigational blood and tissue testing can detect cancer cells in the blood stream can tell if subjects are responding to their individual treatment plans.

Participation will last as long as the subject's individual treatment plan and will consist of collecting tissue biopsies (10 slides), which will be taken during the subject's standard of care procedure, as well as blood draws (between 1 and 2 tablespoons), which will be taken during each of the subject's standard of care clinic appointments throughout their care journey.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects with Non-Small Cell Lung Cancer

Date Added
September 12th, 2023
PRO Number
Pro00128530
Researcher
Mariam Alexander

List of Studies

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

The purpose of this research is to determine the safety and tolerability, the best dose for future development, as well as antitumor activity of a new antibody drug conjugate (ADC) called MYTX-011. MYTX-011 is a new drug, being studied in humans for the first time for treatment of advanced non-small cell lung cancer. The study team is investigating this drug to help treat lung cancers that are resistant to standard medications. This drug targets a protein called cMET on the cancer cell. MYTX-011 will attach to the cMET and release chemotherapy into the cancer cell.

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

Health Education Approach to Lung Screening (HEALS)

Date Added
August 29th, 2023
PRO Number
Pro00130682
Researcher
Marvella Ford

List of Studies


Keywords
Cancer, Lung, Minorities
Summary

The Southeastern Consortium for Lung Cancer Health Equity (SC3), led by Dr. Robert A. Winn, assembles an outstanding interdisciplinary team of translational researchers positioned in the heart of the historical and current tobacco-producing region within the southeast. Collectively, SC3's investigative team has unparalleled experience in lung cancer screening, translational research in lung cancer health disparities, community outreach and engagement, and recruiting and retaining racial and ethnic minorities and individuals from other medically underserved groups using evidence-based strategies. As NCI-designated cancer centers, all three centers report high enrollment of underserved minorities onto interventional trials and are committed to reducing the substantial disparities found in lung cancer outcomes in their collective Black/African American and rural communities.

Institution
MUSC
Recruitment Contact
Ellen Gomez
8438762428
gomezel@musc.edu

A Phase 0 Master Protocol Using the CIVO Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies

Date Added
August 22nd, 2023
PRO Number
Pro00128477
Researcher
Jason Newman

List of Studies

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

This research is being done to better understand how anti-cancer drugs affect cells within a tumor. Injecting very small amounts (microdoses) of pembrolizumab alone or in combination with MK-0482 or MK-4830 above may help the developer of these drugs to understand more about how these drugs work and what changes they make on the tumor. Subjects in this study will have their tumor injected with anti-cancer drugs using a CIVO device. The CIVO device delivers microdoses of multiple drugs or drug combinations directly into the tumor. Some of the procedures in this study include ultrasound assisted placement for tumor injection, a mucrodose injection of anti-cancer drugs into the tumor, and surgery to remove the tumor. Participation in the study will take 5 visits over a period if 56 days. The screening portion will be 28 days and the treatment portion will be 28 days from the time of the injection to the time of follow-up contact by the study team.

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

Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer

Date Added
June 1st, 2023
PRO Number
Pro00118327
Researcher
Robert Grubb

List of Studies


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

The study is for patients that have been diagnosed with low-grade non-invasive upper tract urothelial cancer. The investigational drug used in this study is padeliporfin which is injected into a vein. The main purpose of this study is to learn about the effects and safety of an investigational treatment named padeliporfin Vascular Targeted Photodynamic (VTP) Therapy, in treating low-grade non-invasive upper tract urothelial cancer. Participants can expect to be in this study for up to 18 months. The completion of the study will include up to 9 study visits to the study site and 8 phone visits.

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

A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-positive Acute Lymphoblastic Leukemia (ALL) in Adult

Date Added
May 18th, 2023
PRO Number
Pro00128835
Researcher
Praneeth Baratam

List of Studies

Keywords
Cancer, Cancer/Leukemia
Summary

This study is for patients who have newly diagnosed diagnosed BCR-ABL acute lymphoblastic leukemia (ALL). This study is being done to determine the effects (good or bad) of using the combination of a Tyrosine Kinase Inhibitor (TKI), steroids and blinatumomab versus treatment with steroids, Tyrosine Kinase Inhibitor (TKI) and chemotherapy. This investigational therapy will be added to what has traditionally been used to treat your specific sub-type of ALL. Studies are being done in ALL and other blood cancers with blinatumomab.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843)792-9371
hcc-clinical-trials@musc.edu

UF-HN-004 Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma based on HPV subtype and plasma circulating free HPV DNA Level and Clearance Rate.

Date Added
May 16th, 2023
PRO Number
Pro00124145
Researcher
Bhishamjit Chera

List of Studies

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

This study is for patients that have been diagnosed with Oropharyngeal Squamous Cell Carcinoma. The purpose of this research study is to determine if lower doses of radiation therapy are as effective as the standard higher doses. Participants will have tests and procedures that would be performed as part of regular care. Participants will be assigned to one of three study groups based on your risk for cancer recurrence. Depending on the group assigned, participants receive either standard dose of radiation therapy (RT), a moderately reduced dose of RT, or an extremely reduced dose of RT. During the RT treatment, participants will also receive chemotherapy. Chemotherapy will be given at the same dose used in routine care for everybody in the study. Participants will be in the study for up to 5 years.

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

Southeastern Consortium for Lung Cancer Health Equity (SC3) Biospecimen Repository

Date Added
May 8th, 2023
PRO Number
Pro00128239
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is designed to collect saliva and blood samples from subjects going through the Lung Cancer Screening Program to compare biomarker test results to develop lung cancer clinical risk prediction models further. Also, this study will store blood samples in a biorepository.

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

Southeastern Consortium for Lung Cancer Health Equity (SC3) Biospecimen Repository

Date Added
May 8th, 2023
PRO Number
Pro00128239
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is designed to collect saliva and blood samples from subjects going through the Lung Cancer Screening Program to compare biomarker test results to develop lung cancer clinical risk prediction models further. Also, this study will store blood samples in a biorepository.

Institution
MUSC Health Chester Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu



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