Research


Oncology Trials


Any cancer type


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
Oncology research at 713-704-3961 or ms.oncology.research@uth.tmc.edu


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 at 713-704-3961 or ms.oncology.research@uth.tmc.edu


Oropharyngeal Cancers


A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPCA (Protocol No. EA3161)

The purpose of this study is to compare the usual treatment (the care that most people get for HPV positive oropharynx cancer) alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach for patients with intermediate risk human papillomavirus (HPV) positive oropharynx cancer (throat cancer) that has spread to nearby tissue or lymph nodes.

Please contact:
Syed Jafri, MBBS, at (832) 325-6532 or Syed.H.Jafri@uth.tmc.edu
Oncology research at 713-704-3961 or ms.oncology.research@uth.tmc.edu


Kidney Cancer


PI – Maithel, Neha

Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study

This phase III trial compares the usual treatment (ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Chemotherapy drugs, such as cabozantinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.

Please contact: 

Neha Maithel, MD, at (713) 486-6547 or Neha.Maithel@uth.tmc.edu
Oncology research at 713-704-3961 or ms.oncology.research@uth.tmc.edu


Breast Cancer


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:

Oncology research at 713-704-3961 or ms.oncology.research@uth.tmc.edu


Soft-Tissue Sarcomas


PI – Jones, Jessica

Creating Functional Three-Dimensional Cell Cultures of Surgical Specimens from Sarcoma Patients

The purpose of this study is to use left-over tumor tissue taken from a standard of care biopsy or surgery to create an organoid for each study participant. Researchers will use these models to test the effectiveness of anti-cancer drugs. Because these models are designed to be a very accurate copy of the original cancer, they have the potential to predict how patients will respond to anti-cancer drugs.

Please contact:
Betty Arceneaux at 713-704-3186 or ms.oncology.research@uth.tmc.edu


Malignant Hematology Trials (Blood Cancers)


PI – Rios, Adan

Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients (frontMIND)
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed diffuse large B cell lymphoma (DLBCL).

Please contact:
Oncology research at 713-704-3961 or ms.oncology.research@uth.tmc.edu


Benign Hematology Trials (Non-Cancer Blood Disorders)


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


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


Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat versus Placebo in Subjects with Sickle Cell Disease (Rise Up)

Study Rise Up is a Phase 2/3, double-blind, randomized, placebo-controlled, global, multicenter study evaluating the efficacy and safety of mitapivat versus placebo in subjects with SCD using an operationally seamless design. The Phase 2 portion is a double-blind, randomized, placebo-controlled, dose-finding study evaluating 2 dose levels of mitapivat (50 mg BID and 100 mg BID) versus placebo to select the dose of mitapivat to be evaluated in the Phase 3 portion. The Phase 3 portion is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of mitapivat at the selected Phase 3 dose versus placebo. Subjects who complete the Double-blind Period in either the Phase 2 or Phase 3 portion will have the option to receive mitapivat in the Open-label Extension Period. The initiation of the Phase 3 portion will be based on prespecified go/no-go criteria and dose selection criteria. Subjects who participate in the Phase 2 portion of the study are not eligible to participate in the Phase 3 portion of the study.

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


An Adaptive, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study of T-4202, a Pyruvate\Kinase Activator in Patients with Sickle Cell Disease (Hibiscus)

This study is looking at Etavopivat (FT-4202)  a potent, selective, orally bioavailable, small-molecule activator of pyruvate kinase-red blood cell (PKR) being developed by Forma Therapeutics, Inc and is intended for use as a treatment for patients with sickle cell disease (SCD). The clinical hypothesis is that PKR activation will reduce the rate of sickle cell polymerization and improve red blood cell (RBC) membrane function, thereby reducing RBC sickling and RBC hemolysis that lead to vascular obstruction and anemia, two hallmarks of SCD pathology.

Please contact:
M. Idowu, MD at 713-500-6764 or Modupe.Idowu@uth.tmc.edu
Eyuel Baherey, study coordinator at 713-500-6544 or Eyuel.L.Baherey@uth.tmc.edu


A Randomized, Double-Blind, Placebo-Controlled Evaluation of Single Doses of PF-07209326 in Healthy Participants (Safety, Tolerability, and Pharmacokinetics [PK]) Followed by an Open-Label, Repeat Dose Evaluation in Sickle Cell Disease Participants (Safety, Tolerability, PK and Efficacy) (Pfizer)

This study is evaluating  the initial safety, tolerability, pharmacokinetics, and efficacy following a subcutaneous (SC) multiple dose (MD) of PF-07209326. Efficacy will be evaluated in this cohort based on a novel endpoint, patient-reported vaso-occlusive crisis (VOC) event rate as reported on a SCD VOC diary (electronic Patient Reported Outcome, ePRO) as compared to an external control. Additionally, pharmacodynamic biomarkers which may be associated with the likely mechanism of action following treatment with an anti-E-selectin, will be evaluated. Overall, the data generated from this study will support further development of PF-07209326 for the treatment of SCD.

Please contact:
M. Idowu, MD at 713-500-6764 or Modupe.Idowu@uth.tmc.edu
Eyuel Baherey, study coordinator at 713-500-6544 or Eyuel.L.Baherey@uth.tmc.edu