Research

Active Clinical Trials-Open to Enrollment

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

Lead Physician: Anneliese Gonzalez, MD
Contact: Kaukab Jafry at 832-325-6537 or [email protected]

A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment (Protocol C4391022)

The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor’s choice of treatment in people with advanced or metastatic breast cancer. Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant which will be given as a shot into the muscle. The other half will take the study doctor’s choice of treatment which can either be: fulvestrant alone taken as shot into the muscle; or everolimus along with exemestane taken once daily by mouth.

Eligibility Criteria: This study is seeking female and male participants who: are 18 years of age or older; are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; have advanced or metastatic breast cancer after taking other treatments before this study; have not taken or need to take medications that are not allowed by the study protocol; do not have any medical or mental conditions that may increase the risk of study participation.

A description of this clinical trial including eligibility criteria is available at http://www.ClinicalTrials.gov, as required by U.S. law. ClinicalTrials.gov identifier: NCT06105632

Lead Physician: Anneliese Gonzalez, MD
Contact: Ayodeji (Ayo) Adeniji at 713-500-5570 or [email protected]

Psycho-Spiritual Support for Patients with Advanced Cancer and their Family Caregivers (Protocol 2023-0450)

The goal of this behavioral research study is to learn about the effects of two different supportive care programs on patients’ and their family caregivers’ psychological wellbeing and overall quality of life.

Participants will be asked to answer a set of questionnaires 4 times. Participants will be randomized to 1 of 3 following study groups. All sessions will be online by video conference using Zoom.

Group 1: participants will take part in the family-focused meditation program
Group 2: participants will take part in the family-focused cancer-related discussion program
Group 3: participants will not take part in the family-focused meditation or cancer-related discussion program but will complete the same questionnaires as Group 1 and 2

Eligibility Criteria: Patients must be diagnosed with metastatic (stage IV) breast, thoracic, gastrointestinal, gynecological, or genitourinary cancer; without disease progression for at least 3 months based on CT imaging surveillance; have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; and have a family caregiver willing to consent to participate in this study. Patients and caregivers must be age 18 years and older; able to read and speak English or Spanish and provide consent; and have a NCCN Distress Thermometer score of ≥4.

Lead Physician: Julie Rowe, MD
Contact: Ayodeji (Ayo) Adeniji at 713-500-5570 or [email protected]

A Phase 1/1b, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants with Advanced Solid Tumors (Protocol CP-MGC026-01)

The purpose of this study is to learn about the safety of the test drug MGC026, find the best dosage of the test drug, and to learn if, or how well, the test drug works in participants with locally advanced or metastatic solid tumors whose cancer has progressed during or after standard treatments. The study has a dose escalation and a cohort expansion portion. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse.

Key Eligibility Criteria: You may be able to join this trial if you are 18 years of age or older, have adequate performance status, adequate organ function, and no underlying medical or psychiatric condition impairing your ability to receive, tolerate, or comply with planned study treatment dosing or study procedures.

A description of this clinical trial including eligibility criteria is available at http://www.ClinicalTrials.gov. ClinicalTrials.gov identifier: NCT06242470

Lead Physician: Julie Rowe, MD
Contact: Kaukab Jafry at 832-325-6537 or [email protected]

Pilot Project-1: Impact of race and ethnicity on outcomes in patients with hormone receptor-positive breast cancer treated with CDK4/6 inhibitors

The purpose of this research study is to better understand how social determinants of health (non-medical factors that influence health outcomes, such as treatment delays due to financial burden, distance to treatment site, social support, and environmental factors) may affect:

Medication adherence
1. whether patients take their medications as prescribed
Clinical efficacy
1. whether or not the cancer progresses or becomes more advanced even after treatment; and
2. how long a patient lives after treatment

Participants will be asked to complete two questionnaires on a tablet computer in the waiting or examination room before or after their routine clinic visit or via Zoom. We will also collect some personal and health information. No study visits are required.

Key Eligibility Criteria: ≥ 18 years female patients with hormone receptor-positive breast cancer treated with CDK4/6 inhibitors

Lead Researcher: Rodney J. Hunter, PharmD, BCOP
Contact: Dr. Rodney Hunter at 713-704-3961 or [email protected]

Translational Trials-Open to Enrollment

Biomarkers of Cancer Cachexia: A Prospective Translational Observational Study

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.

Eligibility Criteria: Patients newly diagnosed with advanced Stage IV lung Non-small cell lung cancer (NSCLC) and Small cell lung cancer (SCLC), Gastrointestinal colorectal (CRC), pancreatico-biliary (PBC), gastroesophageal cancers; a weight loss of ≥ 5% of body weight in past 6 months; a serum albumin of < 3.5g/dL or newly diagnosed early stage I/II NSCLC, I/II/III Colorectal cancer (CRC), stage I/II/III Breast cancer (BC) with < 5% body weight loss over past 6 month, serum albumin ≥ 3.5g/dL.

Lead Physician: Syed Jafri, MD
Contact: 713-704-3961 or [email protected]

Development of a Patient-Derived Xenograft Mouse Model of Solid Tumors

The purpose of this research study is to create patient-derived xenograft (PDX) mouse models and patient- derived organoids (PDO). PDX/PDO tumor models are created using a small portion of a patient’s left- over tumor tissue. In this study, researchers want to look at and compare the genetic changes of the tumor models with drug response and/or resistance.

Eligibility Criteria: Patients must be age 18 years and older, with solid tumors, undergoing cancer treatment at UTHealth/Memorial Hermann Hospital-Texas Medical Center, and able to provide a solid tumor sample (from a standard of care biopsy/surgery).

Lead Physician: Julie Rowe, MD
Contact: Betty Arceneaux at 713-704-3186 or [email protected]

Creating Functional Three-Dimensional Cell Cultures of Pathological Specimens from Uncommon Cancer 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.

Eligibility Criteria: Patients must be age 18 years and older, diagnosed with sarcoma or uncommon malignancies such as not but not limited to hepatocellular carcinoma or biliary tract tumors, undergoing cancer treatment at UTHealth/Memorial Hermann Hospital-Texas Medical Center or Memorial Hermann Orthopedic Spine Hospital (MHOSH), and able to provide a tumor sample from a standard of care biopsy/surgery.

Lead Physician: Sanjay Awasthi, MD
Contact: Betty Arceneaux at 713-704-3186 or [email protected]