Research


Oncology Translational Trials – Open to Enrollment


PI – Gonzalez, Anneliese

Tumor Tissue and Laboratory in Breast Cancer
This study is designed to: Evaluate more thoroughly the changes a breast cell goes through as it changes to a tumor; Utilize current CTC technology in an attempt to develop information allowing an earlier diagnosis of metastatic involvement than conventional imaging and laboratory procedures can provide; Identify salivary biomarkers that can assist in the early detection of breast cancer by providing samples to researchers for analysis; Store any remaining specimens not consumed in this protocol for possible future use in breast cancer research.

Please contact:
Krishna Cannon, research nurse, at: (832) 325-6526 or Krishna.Cannon@uth.tmc.edu
Carmela Lewis, research coordinator, at: (832) 325-7297 or Carmela.L.Lewis@uth.tmc.edu


PI – Jafri, Syed

Biomarkers of Cancer Cachexia: A Prospective Translational Observational Study (Protocol No. T-19-101) Grant Title: Identification of Key Tumor Cell-Released Factors That Induce Cachexia
The purpose of this study is to find out if Hsp70 and Hsp90 are biomarkers of cancer cachexia. This information could eventually lead to extend the lifespan and improve the quality of life for cancer patients, and new treatments for this hard-to-treat and often fatal condition.

Please contact:
Syed Jafri, MBBS, at (832) 325-6532 or Syed.H.Jafri@uth.tmc.edu

Major Stressful Events (SE) and Risk of Developing Lung, Head/Neck and Pancreatic Cancer (Protocol No. B-14-104)
The purpose of expanding this research study is to see if major stressful life events (SE) like divorce, death of a family member, or serious financial difficulties can be a risk factor for getting lung, head/neck or pancreatic cancer.

Please contact:
Syed Jafri, MBBS, at (832) 325-6532 or Syed.H.Jafri@uth.tmc.edu
Krishna Cannon, research nurse, at: (832) 325-6526 or Krishna.Cannon@uth.tmc.edu
Carmela Lewis, research coordinator, at: (832) 325-7297 or Carmela.L.Lewis@uth.tmc.edu


Oncology Clinical Trials – Open to Enrollment


Perception of Being Observed in the Absence of Sensory Input, An Experiment in Human Psychology and Demonstration of Observer Effect (Protocol #OB-21-100)
Investigators are seeking 100 UTHealth and Memorial Hermann-Texas Medical Center (TMC) medical students, residents, faculty and healthcare workers to participate in study to investigate whether humans beings have the ability to detect gaze without apparent visual or auditory input pointing towards a more subtle sense of awareness as well as interconnectedness between observer and the observed.

The study involves two study participants and a study personnel. The experiment involves documenting if a person can perceive they are being observed by another person without apparent sensory input. Anticipated time commitment is about 15 – 20 minutes. CDC COVID guidelines for social distancing and masking will be observed.

Please contact:
Syed Jafri, MBBS, at (832) 325-6532 or Syed.H.Jari@uth.tmc.edu
Chandler Nguyen, at (972) 765-4120 or Chandler.H.Nguyen@uth.tmc.edu
Oncology research email at ms.oncology.research@uth.tmc.edu


PI – Jafri, Syed

ALCHEMIST Screening (A151216) – Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial – ALCHEMIST (Protocol A151216)
The screening study will accrue patients that are potentially eligible for the Intergroup adjuvant studies and perform central EGFR and ALK genotyping using a central reference laboratory certified by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Patients may either present prior to surgery with resectable NSCLC, may present following complete resection (before or after adjuvant chemotherapy).

Please contact:
Syed Jafri, MBBS, at (832) 325-6532 or Syed.H.Jafri@uth.tmc.edu
Krishna Cannon, research nurse, at: (832) 325-6526 or Krishna.Cannon@uth.tmc.edu
Carmela Lewis, research coordinator, at: (832) 325-7297 or Carmela.L.Lewis@uth.tmc.edu


PI – Rowe, Julie

TRITON3: A Multicenter, Randomized, Open-label Phase 3 Study of Rucaparib versus Physician’s Choice of Therapy for Patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency (Protocol #CO-338-063)
The is a study of rucaparib versus physicians’ choice of second-line AR-directed therapy (abiraterone acetate or enzalutamide) or docetaxel as treatment for mCRPC patients who have progressed on one prior AR-directed therapy (abiraterone acetate, enzalutamide, apalutamide, or investigational AR-targeted agent) and have not yet received chemotherapy in the castration-resistant setting. This study consists of a Pre-Screening, Screening, Randomization, Treatment, Post-Treatment, and Cross-over Phases.

Please contact:
Julie Rowe, MD, at (713) 500-5369 or Julie.Rowe@uth.tmc.edu
Carmela Lewis, research coordinator, at: (832) 325-7297 or Carmela.L.Lewis@uth.tmc.edu

Emerald I (HCC) – A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination with either Durvalumab Monotherapy or Durvalumab plus Bevacizumab Therapy in Patients with Locoregional Hepatocellular Carcinoma (Protocol No. D933GC00001)
This is a Phase III randomized, double-blind, placebo-controlled, multicenter, global study assessing the efficacy and safety of durvalumab monotherapy and durvalumab plus bevacizumab therapy, compared to placebo, when given with TACE. TACE treatment will be limited to either DEB-TACE or cTACE . This study will be conducted in patients with locoregional HCC not amenable to curative therapy (e.g., surgical resection, transplantation, or ablation). Randomization will be in a 1:1:1 ratio to 1 in one of three treatment arms.

Please contact:
Julie Rowe, MD, at (713) 500-5369 or Julie.Rowe@uth.tmc.edu
Carmela Lewis, research coordinator, at: (832) 325-7297 or Carmela.L.Lewis@uth.tmc.edu

AVEO – A Phase 1b/2, Open-Label, Study of Tivozanib in Combination with Durvalumab in Subjects with Untreated Advanced Hepatocellular Carcinoma (Protocol AV-951-18-121)
This study is designed to evaluate the safety, tolerability, and preliminary antineoplastic activity of Tivozanib in combination with durvalumab in subjects with untreated advanced hepatocellular carcinoma (HCC). Tivozanib, a potent inhibitor of VEGFR phosphorylation, exhibited anti-tumor activity in both preclinical models through inhibition of tumor angiogenesis and vascular permeability. Tivozanib did not have evident direct tumoricidal activities. These data indicate that Tivozanib is a targeted anti-angiogenesis agent.

Please contact:
Julie Rowe, MD, at (713) 500-5369 or Julie.Rowe@uth.tmc.edu


SI – Rowe, Julie

Nanospectra – An Extension Study of MRI/US Fusion Imaging and Biopsy in Combination with Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
This is an open-label, multi-center, single-dose study of AuroLase Therapy in the focal ablation of neoplastic prostate tissue via nanoparticle directed irradiation. The patient population consists of men with low to intermediate risk localized prostate cancer with MRI visible and confirmed focal areas of prostate cancer using MR US Fusion Guided Biopsy.

Please contact:
Julie Rowe, MD, at (713) 500-5369 or Julie.Rowe@uth.tmc.edu
Neha Maithel, MD, at (713) 486-6547 or Neha.Maithel@uth.tmc.edu


PI: Anneliese Gonzalez

An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202) Protocol #7465-CL-202
The goal of this study is to find out if Enfortumab vedotin is effective and safe as a treatment for people with breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer. Researchers will look at how Enfortumab vedotin can act in the body. Enfortumab vedotin is expected to work by attacking cells that have a protein called Nectin-4. This protein is commonly found in cancer cells, specifically the type of cancer you have. Enfortumab vedotin is approved to treat some individuals with urothelial cancer. It is not approved as a treatment for people with the type of cancer you have. The use of Enfortumab vedotin in this study is investigational.

Please contact:
Krishna Cannon at (832) 325-6526 or Krishna.Cannon@uth.tmc.edu


Benign Hematology Trials
Active Clinical Trials-Open to Enrollment


PI- Modupe Idowu

A phase III, Multicenter, Randomized, Double-blind Study to Assess Efficacy and Safety of Two Doses of Crizanlizumab versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Vaso-Occlusive Crises (STAND)

This study will investigate whether Crizanlizumab works and is safe in people with sickle cell disease. People in the study will be 12 years of age or older, and will have had episodes of acute pain crises that led them to the doctor or to the hospital in the last 12 months. Crizanlizumab is a medicine that may stop sickled red blood cells from getting stuck in the blood vessels. This may help lessen the number and severity of acute pain crises caused by blocked blood flow. Your participation in the study may last a little over 5 years and is separated into 3 parts. You will have a clinic visit every month during the study. At these visits, the doctors and study team will run tests to check your health.

Please contact:
M. Idowu, MD at (713) 500-6764 or Modupe.Idowu@uth.tmc.edu
Angelica Rodriguez, study coordinator at (713) 500-6544 or Angelica.R.Rodriguez@uth.tmc.edu

A Prospective Phase II, Open-Label, Single-arm, Multicenter, Study to Assess Efficacy and Safety of SEG101 (Crizanlizumab), in Sickle Cell Disease Patients with Priapism (SPARTAN)

This study will look at the effect of the study medicine Crizanlizumab in sickle cell disease (SCD) patients who are at least 16 years old with a history of priapism (unwanted, painful, and persistent erection, in the absence of sexual activity or desire) for 1 year.  You will be monitored closely throughout the study. It is important that you go to all your visits. This will help the doctors better understand how the study medicine is working. You will have up to 19 planned visits during the study. Visits will take place before you start taking the study medicine, and after you are done taking it. At these visits, the doctors and study team will do tests to check your health.

Please contact:
M. Idowu, MD at (713) 500-6764 or Modupe.Idowu@uth.tmc.edu
Angelica Rodriguez, study coordinator at (713) 500-6544 or Angelica.R.Rodriguez@uth.tmc.edu

A Phase II, multicenter, randomized, open label two arm study comparing the effect of Crizanlizumab + standard of care to standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy (STEADFAST)

STEADFAST is a clinical research study (or clinical trial) comparing the effect of an investigational medication (Crizanlizumab) plus standard of care to standard of care alone on the renal function in sickle cell disease patients with chronic kidney disease due to sickle cell nephropathy. Crizanlizumab is already approved in some countries to reduce the frequency of vaso-occlusive crises (VOCs) in patients aged 16 years and older with sickle cell disease but has not been studied in patients with chronic kidney disease. Participants will be treated with either the standard of care alone or the standard of care plus the monthly infusion of Crizanlizumab (following the initial infusion plus one extra infusion after 2 weeks). The study is open label which means you and your doctor will know which treatment you are receiving. If you qualify and choose to join the study, you will be on treatment for approximately 1 year. After completing treatment, your doctor will follow up with you over the phone to collect information about your health and your CKD due to SCN.

Please contact:
M. Idowu, MD at (713) 500-6764 or Modupe.Idowu@uth.tmc.edu
Angelica Rodriguez, study coordinator at (713) 500-6544 or Angelica.R.Rodriguez@uth.tmc.edu

Sickle Cell Disease and Cardiovascular Risk – Red cell Exchange Trial (SCD-CARRE NIH)

The purpose of this study is to see the effects of giving long-term red blood cell exchange transfusion to patients with sickle cell disease (SCD). We want to know if exchange blood transfusion may help with complications of SCD or reduce the chances of new serious problems happening. Usual care, or standard of care, is the plan a physician should follow when caring for patients. We will compare usual care for SCD alone, to exchange blood transfusion along with usual care, to see the effects of exchange transfusion.  If you are eligible for the study, a computer will randomly put you in one of two study groups. Group 1 will get the usual care for SCD. Group 2 will get an exchange transfusion every 3-6 weeks for 12 months, plus the usual care for SCD. Everyone in the study will have tests, exams, and blood draws every month, and will complete an echocardiogram, walk test, activity monitoring, and quality of life and pain questionnaires every 4 months throughout the study.  The study will last about 13 months.

Please contact:
M. Idowu, MD at (713) 500-6764 or Modupe.Idowu@uth.tmc.edu
Angelica Rodriguez, study coordinator at (713) 500-6544 or Angelica.R.Rodriguez@uth.tmc.edu

A randomized, placebo-controlled, double blind, single ascending and multiple ascending dose study to assess the safety, pharmacokinetics and pharmacodynamics of FT-4202 in healthy volunteers and sickle cell disease patients

FT-4202 is an investigational drug that has been developed to treat patients with sickle cell disease. It is known to interact with a chemical found in the RBCs, specifically Pyruvate Kinase-red blood cell, or PKR, which may decrease the sickling and damage of the RBCs of the patients who have the disease. The purpose of the MAD SCD part of this research study is to Evaluate the safety and tolerability of multiple ascending doses of FT-4202 when administered to subjects with SCD Measure how much FT-4202 gets into the bloodstream over time following multiple doses, when given to subjects with SCD.to determine the effect of FT-4202 on the Red Blood Cells (RBCs) in subjects with SCD after multiple doses of FT-4202.

Please contact:
M. Idowu, MD at (713) 500-6764 or Modupe.Idowu@uth.tmc.edu
Angelica Rodriguez, study coordinator at (713) 500-6544 or Angelica.R.Rodriguez@uth.tmc.edu

Benign Hematology Basic Science Research