Cancer Clinical Trials

Cancer clinical trials open for participants

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.

• 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, Email

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, Email

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, Email

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, Email

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