Scott Tomlins, MD, PhD

Working with Astellas/Medivation, I designed the correlative studies and am the central pathologist for a nationwide phase II trial of enzalutamide (an androgen receptor inhibitor) or placebo in men with low risk prostate cancer who are electing to delay curative surgical or radiation treatment (“active surveillance”). NCT02799745, IRB HUM00112108, opened Spring of 2016.

I am also the pathology and biomarker lead for a trial comparing standard androgen deprivation therapy (ADT) versus ADT + palbociclib (a cyclin dependent kinase inhibitor) for men with newly diagnosed metastatic prostate cancer. This trial is led by Dr. Maha Hussein at UM, and was funded through the Prostate Cancer Foundation. Correlative biomarker studies will be performed in my lab through Taubman Institute support. NCT02059213, HUM00082715, completing accrual in the Fall of 2016).

Johann Gudjonsson, MD, PhD

Clinical trials: Please provide a lay-friendly description of any clinical trials you have initiated in the past two years or
any anticipated in the next 12 months. Please provide IRB number and ClinicalTrials.gov NCT number for each
study.

Current (1):
Investigator Sponsored Research Agreement for Amgen Protocol No 20129105
Amgen, Inc. – Prime Sponsor    12/12/13 to 07/31/17  Immunex Corporation – Direct Sponsor   $516,183 total project budget
“The immunological basis for treatment resistance to anti-TNF treatments”
IRB Number:  HUM00070592     ClinicalTrials.gov NCT Number: 1971346 The major goal of this project is to determine if there is an imbalance between the strength of two inflammatory mediators in skin; TNF-alpha and the type I interferon, interferon alpha, in psoriatic skin and whether the balance between the two  influences treatment response with the anti-TNF agent etanercept.

Current (2):
“The Effect of Riboflavin on Moderate to Severe Plaque Type Psoriasis”
IRB Number: HUM00105691 ClinicalTrials.gov NCT Number: 02622386
 This clinical trial seeks to determine the anti-inflammatory effect of high-dose riboflavin supplementation on chronic plaque psoriasis.  Data generated in my laboratory has shown that psoriasis plaques have significantly less riboflavin (vitamin B2) than healthy controls.  70 year old clinical studies have indicated that riboflavin is clinically effective for the treatment of psoriasis – however, given the advent of topical steroids at the same time riboflavin fell to the wayside and hasn’t been addressed ever since. Interestingly, riboflavin deficiency can lead to skin inflammation that has many clinical features in common with psoriasis, including red scaly skin.  This is a prospective double-blind clinical trial involving 50 patients treated with 400mg of vitamin B2 (riboflavin a day).  We anticipate having data from this trial by mid-to-end of 2017.

Thomas Gardner, M.D., M.S.

The broad goal is to develop improved means to diagnose and treat diabetic retinopathy. Central to this goal is the need to better understand how diabetes damages retinal nerve and blood vessel cells. This question has to be addressed indirectly because we cannot biopsy the retina, unlike most other tissues. Therefore, we measure how diabetes impairs various aspects of vision—central vs peripheral retina, and how diabetes causes normal retinal tissue to be lost. We are using tests that reveal the cellular structure of the human retina. For example, in one study we are comparing three forms of visual field tests in patients with various degrees of retinopathy severity (HUM00099155). In another study we are investigating how damage to the peripheral retina determines response to treatment of swelling of the central retina (HUM00109572). Moreover, we will examine how retinopathy can be detected in children with diabetes (HUM00110630). Note, these are observational studies, and as such, are not registered with clinicaltrials.gov. The data will be essential to the preparation of a grant proposal to the NIH to expand the use of these tests as endpoints to care for patients. In particular, these studies will be crucial to evaluate the potential for gene therapy in patients with diabetic retinopathy.

Additionally, we are utilizing visual field tests to determine effects of pre-diabetes (HUM00092638) and of bariatric surgery (HUM00109572) on the retina in collaboration with Dr. Brian Callaghan.

Arul M. Chinnaiyan, M.D., Ph.D.

1) Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes: FGFR1, FGFR2, FGFR3, FGFR4, RET, KIT; HUM00101697;

NCT02272998 2) Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer; HUM00060473; NCT 01576172

Frank C. Brosius III, M.D.

A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease IRB:  HUM00065535 ClinicalTrials.gov: NCT01683409

Alon Kahana, MD, PhD

NCT: 02436408; IRB: HUM00082579
Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat. Treatment of facial BCCA typically includes Mohs micrographic surgery followed by plastic reconstructive surgery. Success rates of treatment for non-metastatic BCCA that is limited to skin can approach 99%. However, deeply invasive BCCA can involve vital organs, such as the eye or lacrimal drainage system, requiring aggressive surgical interventions that often compromise organ function. Hence, there is a critical need for improved treatments of invasive BCCA in the face.