Cancer

Below are current clinical trials.

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1. Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

   Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of part one of this study is to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and safety profile of Q901 monotherapy when administered via intravenous (IV) infusion once-weekly (QW) for 4 weeks and once every 2 weeks (Q2W) thereafter. Also, to establish for future clinical development the recommended Phase 2 dose (RP2D) of Q901 monotherapy when administered via IV infusion QW for 4 weeks and Q2W thereafter. 

   The purpose of part two of this study is to evaluate safety and tolerability and evidence of anticancer activity of Q901 as monotherapy and in combination with pembrolizumab. In Part 2 Cohort 1, an expansion phase at the established RP2D will be undertaken in participants with selected advanced solid tumors. In Part 2 Cohort 2, a safety run in and expansion phase will be undertaken with Q901 at the RP2D administered in combination with pembrolizumab (400 mg Q6W) in participants with advanced solid tumors.

2. Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

   Rochester, Minn.

   The purpose of this study is to determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma.

   Furthermore, to determine if open surgical resection is superior to thoracoscopy for event free survival (EFS), for overall survival (OS), and if thoracoscopy is superior to open surgical resection for postoperative pain interference in patients with resectable oligometastatic pulmonary osteosarcoma.

3. Cerebrospinal Fluid Biomarkers for Brain Tumors

   Rochester, Minn.

   The purpose of this study is to help generate a repository of Cerebrospinal  Fluid (CSF) samples relevant to neuro-oncology research that may facilitate the identification of biomarkers that are predictive of disease burden, therapeutic susceptibility or response to therapy. This protocol will also provide a vehicle for CSF access for patients or providers wishing to generate or evaluate individualized biomarkers as part of other research or individualized therapy protocols.

4. Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors, The PNeoVCA Study

   Jacksonville, Fla.

   The purpose of this study is to determine the safety and tolerability of personalized neoantigen peptide administered in combination with pembrolizumab to patients with advanced solid tumors. Patients' tumors will be sequenced during a pre-registration component or will have had successful sequencing pre-study. A personalized neoantigen peptide vaccine containing up to 20 unique peptides will be manufactured for each qualifying patient based on the results.

5. Breath Condensate of Lung Cancer Patients and Healthy Controls to Measure RNA Species in Exhaled Breath Condensate

   Rochester, Minn.

   The purpose of this study is to develop tests for early detection of lung cancer or lung fibrosis based on multiomics analyses of patients’ breath condensates.  

6. A Study to Validate DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection

   Rochester, Minn.

   The purpose of this study is to validate candidate universal and site-specific methylated DNA markers (MDMs) in DNA extracted from formalin-fixed paraffin embedded primary tumor and control specimens.

7. A Study to Collect Surgical Tumor Samples for Prostate Cancer-derived Tissue Graft

   Rochester, Minn.

   The purposes of this study are to collect prostate surgical samples from metastatic patients to establish xenograft tumor lines for future testing of potential therapies and for understanding mechanisms of therapy resistance via DNA/RNA sequencing, to collect patient blood samples for future DNA/RNA sequencing , and to collect patient urine samples for future prostate cancer related biomarker detection and DNA/RNA sequencing.

8. First In Human Study Of TORL-1-23 In Participants With Advanced Cancer

   Rochester, Minn.

   This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer

9. Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery

   Scottsdale/Phoenix, Ariz., Rochester, Minn.

   This phase II trial studies how well sapanisertib works in treating patients with pancreatic neuroendocrine tumor that has spread to other places in the body, does not respond to treatment, or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or shrink tumor cells by blocking some of the enzymes needed for cell growth

10. A Clinical Use Application for the Humanitarian Use Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Primary or Secondary Liver Neoplasia

    Eau Claire, Wis.

    This protocol allows multiple treatments with TheraSphere® that may be delivered on an outpatient basis. Patients may receive a single dose to a liver lobe or segmental treatment delivered as a sequence of treatments approximately 30-90 days apart. The principal clinician, working with a multidisciplinary team, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy and the desired goal of treatment.