Clinical Trials & Research
Laboratory ResearchPier Paolo Pandolfi, MD, Ph.D., FRCP, Senior Scientist Renown Institute for Cancer
The Pandolfi lab has conducted research that has led to major breakthroughs in the understanding, treatment, and definitive cures of cancer. This research is currently ongoing at the Renown Institute for Cancer. Laboratory studies have been seminal at revealing the molecular mechanisms and genetics underlying leukemias and solid tumors' pathogenesis, enabling the team to model these cancers in mice.
We have characterized the fusion oncoproteins' function and the genes involved in the chromosomal translocations of acute promyelocytic leukemia (APL) and major tumor suppressors, such as PTEN p53, and novel cancer genes, such as POKEMON, INPP4B, and WWP1. Critically, our work to uncover the molecular basis underlying APL pathogenesis and modeling this leukemia in the mouse led to the development of novel and effective therapeutic strategies. Based on these findings, APL is now considered a curable disease. Novel therapeutic concepts have emerged from this work and are currently being tested in multiple clinical trials in leukemia and solid tumors such as prostate and breast cancers.
Additionally, discovery platforms have been developed through the systematic use of faithful mouse models of cancers (e.g., the "Mouse Hospital" and the "Co-Clinical" trial project), allowing us to study genetic alterations associated with the disease but can be used for the human/mouse Co-Clinical integrated assessment of new therapeutic modalities. These platforms will now be developed at Renown, leveraging genetic information that stems from the Healthy Nevada Project regarding cancer susceptibility and response to therapy.
Furthermore, more recent work led to transformative studies revealing that non-coding RNAs regulate basic biological processes such as growth and tumorigenesis, thus dispelling long-held beliefs that non-protein-coding genes in the human genome were "junk." This work uncovered a new hidden code whereby these "junk" genes can function and talk to each other. This new scientific dimension is almost mind-boggling in its scope, as the number of genes that encode non-coding RNAs is approaching the 100,000 mark, vastly expanding the size of the functional genetic units present in our genome. These discoveries have already sparked the development of new drugs targeting specific non-coding RNAs to treat disease in patients, including the Covid-19 Pandemic. Once again, non-coding RNAs biology and genetics will be now developed at Renown Institute for Cancer, in collaboration with the Healthy Nevada Project (HPN) team of geneticists and bioinformaticians.
Dr. Pandolfi received both his MD and Ph.D. (Molecular and Cellular Biology) from the University of Perugia in Italy. In 2007, he received an Honorary Master's Degree from Harvard Medical School and is a Distinguished Honorary Professor of Cancer Genetics & Molecular Biology, Molecular Biotechnology Center, University of Turin. From 2013 to 2020, he served as the Cancer Center Director of Beth Israel Deaconess Medical Center / Harvard Medical School.
Joseph J. Grzymski, Ph.D., Chief Scientific Officer, Renown Health; Research Professor Computational Biology and Genetics, Desert Research Institute
Joseph Grzymski, Ph.D., is responsible for expanding DRI's applied research portfolio and has received funding over $50m from a variety of federal, state, and private sector sources. Dr. Grzymski is the Healthy Nevada Project principal investigator and now leads a diverse team of 40 geneticists, data scientists, programmers, engineers, clinicians, and doctors as a part of the Renown Institute for Health Innovation, which functions between Renown and DRI.
The Healthy Nevada Project (HNP) is a population genetics study that has enrolled, consented, and collected DNA and other health determinants data from more than 50,000 participants throughout Nevada. There are two society-scale value propositions for the HNP: 1) increase educational attainment and economic output via population health strategies to improve health outcomes; 2) a prevention strategy using genetics to detect inherited disease risks for conditions, if detected early, lower mortality and morbidity. This risk assessment is poorly ascertained in the current clinical setting.
In Genomic Medicine, the HNP is currently returning results of CDC Tier 1 conditions to the consented participants of the HNP while focusing research efforts on lifestyle diseases such as cardiovascular disease, respiratory disease, diabetes, liver disease, and addiction. Dr. Grzymski is also the PI of a significant genetics study on NASH risk sponsored by Gilead Sciences and the PI of an NIH R01 grant focusing on gene x environment interactions related to cancer risk.
Dr. Grzymski maintains an active research lab in basic and applied research related to DNA damage and the transcriptional regulation of metabolism related to stress. He works with a variety of federal agencies on population genomics best practices. Dr. Grzymski received his Ph.D. from Rutgers University, was a postdoc at Rockefeller University, was a Fulbright Scholar, and is a graduate of Bowdoin College.
Cancer Clinical Trials & ResearchParticipating in cancer clinical trials and research allows you to receive the most effective therapy available. These treatments investigate promising new drugs, drug combinations, advances in personalized care, and new approaches to surgery or radiation therapy otherwise unavailable.
To join a clinical trial, talk to a member of your cancer care team. They will know about any current trials for your type of cancer, explain your role in the preparation, and provide information about your protection. Trial participants usually receive the therapy at little or no cost.
If you are considering a trial, consult with your primary care doctor.
At Renown Institute for Cancer, we want to provide our patients with the opportunity to access novel treatments through participation in clinical trials.
For adult patients we offer clinical trials through the National Cancer Institute Community Oncology Research Program (NCORP) (https://ncorp.cancer.gov). Dr. Garrett Green, Renown Health Department of Radiation Oncology, serves as the Principal Investigator and Liaison for the adult oncology team. For specific information on which trials are currently available at our institution, please call t us at 775-982-5050.
For children we offer clinical trials, including phase 2 and phase 3 studies, through the Children’s Oncology Group (https://childrensoncologygroup.org). Dr. J. Martin Johnston, Chief of Pediatric Hematology/Oncology at Renown Children’s Hospital and Senior Investigator, Renown Institute for Cancer, is the Principal Investigator.
Current Clinical Trials
METIS: Lung Cancer
Pivotal, Open-label, randomized study of Radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from Non-Small Cell Lung Carcinoma (NSCLC).
The purpose of the study is to obtain information on the safety and effectiveness of advanced NSCLC patients following stereotactic surgery (SRS) for 1-10 brain metastases, treated with NOVO TTF (100M)(an investigational device) compared to support treatment alone. The study is a randomized control Phase III trial in adult patients ages 18 years and above, diagnosed with NSCLC and who developed brain metastases. The duration of the study is 36 months. In order to be included, you will need to be enrolled within 21 days of the diagnosis of brain metastasis.
LUNAR EF-24: Lung CancerPivotal, randomized, open-label study of Tumor Treating Fields (TTFields)concurrent with standard of care therapies for treatment of stage 4 non-small cell lung cancer (NSCLC) following platinum failure.
The purpose of this study is to test the efficacy and safety of TTFields, using the NovoTTF-100L System, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment. This is a device study and design as a prospective, randomized control, open-label study. Study population are patients diagnosed with stage 4 NSCLC, and are above 22 years of age following disease progression on or after receiving platinum based chemotherapy. The duration for this study is 48 months. Patients must be randomization within 28 days of diagnosis of last progression and show absence of brain metastases to be eligible.
GTI-4419-301: ROMAN - Head and Neck CancerROMAN: Reduction in Oral Mucositis With Avasopasem Manganese (GC4419) - Phase 3 Trial in Patients Receiving Chemoradiotherapy for Locally-Advanced, Non-Metastatic Head and Neck Cancer.
The purpose of study is to assess the effect of GC4419 administered intravenously on the incidence and severity of severe oral mucositis in subjects receiving therapy with single-agent cisplatin plus Radiation Therapy (IMRT) for locally advanced, non-metastatic squamous cell carcinoma (SCC) of the oral cavity or oropharynx. Secondary objective is to confirm safety and tolerability of GC4419. GTI-4419-301 is a randomized, double-blind, placebo-controlled, multi-center international study conducted to evaluate GC4419 administered IV in adult patients who have confirmed diagnosis of squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent radiation therapy. The duration of this trial is approximately 35 doses, on days in which radiation therapy is administered, for approximately 7 weeks with a follow up period of 2 weeks. All subjects will be then followed for one year post-treatment for tumor recurrence/progression. GC4419 will be administered for approximately one hour before each dose of radiation therapy.
QNM-CA-101: Specimen Collection From Patients With Non-Hematologic Cancer for Use in Development of a Liquid Biopsy AssayThis specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS).
MonarchE: Breast CancerEndocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer (monarchE).
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
Forward IIStudy of Mirvetuximab Soravtansine in Comb. With Bevacizumab, Carboplatin, PLD, Pembrolizumab, or Bevacizumab + Carboplatin in Adults With FRa + Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer.
This is a phase 1b/2 study to assess the safety, tolerability, and preliminary anti-tumor activity of IMGN853 when administered with chemotherapy. Patients will be assigned to one of five regimens: IMGN853 administered with bevacizumab, IMGN853 administered with carboplatin, IMGN853 administered with pegylated liposomal doxorubicin, IMGN853 administered with pembrolizumab, or IMGN853 administered with bevacizumab+carboplatin.