Research

Oncology Trials

Any cancer type

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

Role of Major Stressful Life Events in Development of Cancer
Psychological stress has been shown to be related to suppression of immunity. A suppressed immune system may in turn lead to the development of cancer. The purpose of this research study is to assess if there is a difference in certain immune mediators/chemicals in the blood of patients with newly diagnosed cancer and a history of major stressful life events in comparison to patients with newly diagnosed cancer and healthy controls with no history of major stressful events in the past one year. This study requires one study visit where participants will sign the consent form, complete a questionnaire, and have blood drawn.

Eligibility Criteria:

Patients must be age 18 years and older, with

either recent diagnosis of cancer before start of treatment with major stressful life event within past one year (death of loved one, loss of job, divorce, major financial stress etc.)
recent diagnosis of cancer before start of treatment with no major stressful event in past one year.
no cancer diagnosis (healthy controls), and no major stressful event in past one year.

Participants will also need to meet other secondary eligibility criteria.

Please contact:
Syed Jafri, MBBS, at 832-325-6532 or Syed.H.Jafri@uth.tmc.edu
Kaukab Jafry at 832-325-6537 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)
Sponsor: National Cancer Institute (NCI)/ECOG – ACRIN and Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT0381101

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.

This study consists of 3 arms:

Experimental: Arm A (cisplatin, IMRT, nivolumab)

Patients receive cisplatin IV over 60 minutes weekly and IMRT 5 days a week for 7 weeks for a total of 35 fractions. Within 4 weeks after completion of concurrent therapy, patients receive nivolumab IV once weekly over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.

Active Comparator: Arm B (cisplatin, IMRT, observation)

Patients receive cisplatin IV over 60 minutes weekly and IMRT 5 days a week for 7 weeks for a total of 35 fractions, and then go on observation.

Patients will be offered the option to cross-over to Arm C if they have clearly documented progression within 12 months from the end of cisplatin/radiation therapy.

Experimental: Arm C (nivolumab)

Patients receive nivolumab IV over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.

A description of this clinical trial is available on http://www.ClinicalTrials.gov, as required by U.S. Law.

Please contact:
Syed Jafri, MBBS, at 832-325-6532 or Syed.H.Jafri@uth.tmc.edu
Khola Khan at 713-500-6919 or Khola.Khan@uth.tmc.edu

Lung Cancers

Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer [Sponsor: National Cancer Institute]
This phase III trial studies how well an antibody (durvalumab) with chemotherapy and radiation (chemoradiation) therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if adding durvalumab to standard chemoradiation followed by additional durvalumab can extend patients life and/or prevent the tumor from coming back compared to the usual approach of chemoradiation alone followed by durvalumab.

The study has 2 steps:

Step 1 involves Arm A (durvalumab 750 mg IV every two weeks, three doses with chemotherapy, and concurrent radiation therapy) and Arm B (three doses of chemotherapy and concurrent radiation therapy).
Step 2 involves Arm C (consolidative durvalumab 1500 mg IV every four weeks for one year after the end of Step 1 chemotherapy and radiation).

A description of this clinical trial is available on http://www.ClinicalTrials.gov, as required by U.S. Law. ClinicalTrials.gov Identifier: NCT04092283

Please contact:
Syed Jafri, MBBS, at 832-325-6532 or Syed.H.Jafri@uth.tmc.edu
Khola Khan at 713-500-6919 or Khola.Khan@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
Kaukab Jafry at 832-325-6537 or Kaukab.I.Jafry@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

Protocol: Comprehensive Outcomes for After Cancer Health (COACH) [Sponsor: Pack Health, A Quest Diagnostics Company]
COACH is a study currently being conducted across the country to learn more about the health and well-being of individuals who have completed their primary cancer therapy. This study also evaluates if and how a digital coaching intervention may help support individuals and improve their outcomes.

The study consists of 2 groups:

6 months of coaching followed by 6 months of monitoring
6 months of monitoring followed by 6 months of coaching

Participants will be asked to:

Answer surveys up to once per month
Wear a Fitbit® for 12 months, even if you have another device
Collect a stool sample at enrollment and at 6 months

A description of this clinical trial including eligibility criteria is available on http://www.ClinicalTrials.gov, as required by U.S. Law. ClinicalTrials.gov Identifier: NCT05349227

Please contact:
Dr. Jessica Jones at 832-325-7703 or Jessica.T.Jones@uth.tmc.edu
Kaukab Jafry at 832-325-6537 or Kaukab.I.Jafry@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

Benign Hematology Trials (Non-Cancer Blood Disorders)

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