Clinical Trials

Cancer clinical trials open for participants

Harold C. Simmons Comprehensive Cancer Center
Harold C. Simmons Comprehensive Cancer Center

Patients at UT Southwestern’s Harold C. Simmons Comprehensive Cancer Center, the only NCI-designated cancer center in North Texas, have access to treatment options that would otherwise be unavailable to them in the region. NCI-designated comprehensive cancer centers are committed to making available the latest technologies for imaging and diagnosing and to tailoring treatments to a patient’s specific situation.

As one of only 30 U.S. cancer research centers named a National Clinical Trials Network Lead Academic Participating Site, UT Southwestern participates in and, in many cases, its physicians and researchers serve as principal investigators of numerous clinical trials in a variety of diseases.

Below is a small sampling of cancer clinical trials at UT Southwestern that are currently recruiting appropriate patients.

 

CLINICAL TRIAL: Randomized trial of adjuvant curcumin after radical prostatectomy

Summary This is a prospective study to determine if the use of adjuvant curcumin randomized against placebo will reduce recurrence from prostate cancer after radical prostatectomy.

Patient eligibility A patient may be eligible for this trial if he:

  • Has a status of post-radical prostatectomy for histologically confirmed adenocarcinoma of the prostate
  • Is pathologically confirmed with stage pT1-T3, pN0, M0 disease
  • Is 30-80 years old at time of diagnosis with a life expectancy of at least 3 years

Currently enrolling with a goal of 600 patients.

PI: Yair Lotan, M.D.

Clinical Research Manager: Allison Beaver, RN, 214-645-8788,

allison.beaver@utsouthwestern.edu

 

CLINICAL TRIAL: An open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of VT-464 in patients with advanced breast cancer

Summary This is an open-label study aiming to determine the safety and effectiveness of the androgen receptor inhibitor VT-464 in patients with advanced breast cancer.

Patient eligibility Patients with androgen-receptor positive, triple-negative, unresectable, locally advanced or metastatic breast cancer or postmenopausal women with estrogen-receptor positive/HER2 normal breast cancer are potentially eligible for this study.

PI: Barbara Haley, M.D.

Clinical Research Manager/Coordinator: Valerie Clark, 214-648-7041,

valerie.clark@utsouthwestern.edu

 

CLINICAL TRIAL: A study of neratinib plus capecitabine versus lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have received two or more prior HER2-directed regimens in the metastatic setting

Summary This is a randomized, multicenter, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine for HER2+ metastatic breast cancer patients who have received prior therapy directed for HER2+ metastatic breast cancer.

Patient eligibility Patients must have histologically confirmed metastatic breast cancer with documented HER2 overexpression or gene-amplified tumor (IHC 3+ or IHC2+ with confirmatory FISH+) and must have had at least two prior HER2-directed therapies for metastatic breast cancer.

PI: Barbara Haley, M.D.

Clinical Research Manager/Coordinator: Valerie Clark, 214-648-7041,

valerie.clark@utsouthwestern.edu

 

CLINICAL TRIAL: Phase 3 randomized, double-blind controlled study of ICT-107 in glioblastoma

Summary This is a phase III study of ICT-107 with maintenance temozolomide (TMZ) in newly diagnosed glioblastoma following resection and concomitant TMZ chemoradiotherapy. ICT-107 is a dendritic cell vaccine injected subcutaneously into axillae. Induction phase consists of ICT-107 injections once a week for four weeks (no TMZ), followed by maintenance phase of monthly ICT-107 injections for 11 months with six monthly cycles of TMZ, and then every six months until progression.

Patient eligibility A patient may be eligible for this trial if he/she is newly diagnosed with glioblastoma, a first-line trial patient, HLA-A2 positive only with gross total resection.

PI: Edward Pan, M.D.

Clinical Research Manager: Pamela Kurian, 214-648-5874,

pamela.kurian@utsouthwestern.edu

 

Safeguarding patients’ interests

Everyone who participates in clinical trials at UT Southwestern is a volunteer and can choose to stop his/her participation in the trial at any time. When conducting clinical trials, UT Southwestern’s most important responsibility is to protect research volunteers through well-designed protocols, a dedicated Institutional Review Board (IRB), and a carefully informed consent process. UT Southwestern has a designated Research Participant Advocate who can help potential trial participants by:

  • Finding studies recruiting volunteers
  • Finding information about a study
  • Communicating with the study team
  • Listening to patient questions, concerns, and complaints and finding answers

Contact the Research Participant Advocate:

Kate Wilkinson, M.S.

214-648-6339

kathleen.wilson@utsouthwestern.edu

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