肿瘤科（内科）

以下为当前的临床试验。

按院区、状态和其他条件筛选该研究列表。

1. A Study of Safety, Tolerability, Pharmacokinetic and Pharmacodynamics (PK/PD) in Patients With Hematologic Malignancies

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

   The purpose of this study is to evaluate the safety and tolerability of APG-2575 as well as dose escalation and dose expansion stages.

2. International Hepatobiliary Neoplasia Registry and Biorepository

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

   This study is being done to:

   1. Create a registry of patients having or at risk for cancer of the liver or bile ducts (also known as hepatocellular carcinoma or cholangiocarcinoma), or gallbladder cancer, and those individuals who have normal risk factors in order to improve the ability to diagnose and treat these cancers. We will use information in the medical record in this registry including how far advanced the cancer is (stage) and what treatments are used to treat the cancer.

   2. A second purpose of this study is to obtain blood and tissue samples from participants having or at risk for developing cancer of the liver or bile ducts or gallbladder cancer to be used for future research testing. Future testing may include searching for changes in the genetic material (DNA and other molecules).

3. A Study to Evaluate Olaparib and Temozolomide in Treating Patients With Advanced, Metastatic, or Unresectable Uterine Leiomyosarcoma

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

   The purpose of this study is to evaluate olaparib and temozolomide in treating patients with uterine leiomyosarcoma (LMS) that has spread to other places of the body or cannot be removed by surgery. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving olaparib and temozolomide may work better than giving either drug alone in treating patients with LMS.

4. A Study to Determine the Effect of Distance Reiki on Patient Reported Quality of Life (PRQoL) and Immunity Among Multiple Myeloma Patients

   Rochester, Minn.

   This study aims to demonstrate acceptability and feasibility of the use of Distance Reiki therapy versus sham Reiki therapy among multiple myeloma patients.It also aims to determine if there is a minimal clinically meaningful improvement in various QOL domains (Physical, Social, Emotional), overall QOL with use of Patient-Reported Outcomes Measurement Information System (PROMIS-29) and Single Item Linear Analogue Scale (LASA) after Distance Reik. Lastly, it aims to analyze the effect of Distance Reiki on expansion of the immune repertoire by comparing immune repertoires at baseline and at the end of the study by using Mass spectrometry by CyTOF® and  multiplex polymerase chain reaction (PCR) sequencing of the T-cell receptors (TCRs) for assessment of immune repertoire diversity by iRepertoire®.

5. Profiling of Lung Cancer for Identification of Treatment Targets and Strategies

   Jacksonville, Fla.

   The purpose of this research trail is to study the genetic alteration/mutation and immune profiling in surgical resected Non-small Cell Lung Cancer (NSCLC) tumor samplesand to investigate the correlation between genetic alteration/mutation status and tumor immune micro-environment.

    

    

    

6. Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis

   Jacksonville, Fla.

   This is a prospective, pilot, single arm study to evaluate the incidence of IIC in patients with solid malignancies receiving VSL#3 and ICIs. Given the fact that the effects of over-the-counter probiotics in reducing the risks of IIC remains largely unknown. Given that this is a small pilot study to generate preliminary data, there will be no randomization in this trial. The results of this trial will provide a foundation for the future development of larger definitive randomized controlled trials. Patients with solid malignancy who will be receiving ICI as per standard of care will be enrolled in this trial.  Patients will receive VSL#3® 450B sachets probiotics, which will be provided as part of this trial, at least 3 days but preferably 1-2 weeks prior to starting on ICIs. Patients will be followed per standard of care during ICI treatment and continue VSL#3 for 12 more weeks while on ICI. Patients will complete dietary questionnaire and have research blood draws and stool collections at baseline prior to starting VSL#3 and 3 additional time points. Adherence to the probiotic schedule will be captured in a study diary.  Adverse events as well as incidence and severity of IIC will be graded using NCI CTCAE version 5. Patients will have imaging performed per standard of care.

   Primary Goal

   • To evaluate the incidence of immune checkpoint inhibitors (ICI)-induced colitis (IIC) in patients with solid malignancies receiving over-the-counter multi-strain probiotic blend and ICIs in both cohorts: (1) anti-CTLA-4 +/- anti-PD-1/PD-L1, and (2) anti-PD-1/PD-L1 +/- chemo.  

   Secondary Goals

   • To evaluate the safety of multi-strain probiotic blend in cancer patients receiving ICIs.
   • To evaluate the clinical outcomes related to IIC, including the incidence of IIC, hospitalization, treatment delays, and administration of immunosuppressants.

   Exploratory Goals

   • To evaluate changes in gut microbiome with ICIs and multi-strain probiotic blend.
   • To evaluate changes in immune response with ICIs and multi-strain probiotic blend.

7. A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ

   Rochester, Minn., Jacksonville, Fla.

   This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.

8. Effect of Agent Orange Exposure on Endocrine Tumor Aggressiveness

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

   The intent is to collect relevant clinical data on patients exposed to Agent Orange plus assessment of the tissue for genetic mutations known to be associated with growth of thyroid cancer and pituitary tumors and report our findings as a descriptive case series.

9. Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients

   Scottsdale/Phoenix, Ariz., Rochester, Minn.

   This is a phase II multi-center study of nab-paclitaxel, gemcitabine and cisplatin (NGC triple regimen) as preoperative therapy in potentially resectable pancreatic cancer patients. DISEASE STATE - Potentially operable or borderline resectable pancreatic adenocarcinoma as assessed by standard CT criteria and histologically confirmed. - Staging by pancreatic protocol, helical abdominal computed tomography (with contrast) or MRI (with contrast) required (endoscopic ultrasound is not required). - No evidence of metastatic disease. Lymphadenopathy (defined as nodes measuring >1 cm in short axis) outside the surgical basin (i.e., para-aortic, peri-caval, celiac axis, or distant nodes) is considered M1 (unless nodes are biopsied and are negative, then enrollment can be considered after review with the study PI). Potentially Resectable Pancreatic Cancer - No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (SMA) and, if present, replaced right hepatic artery. - No involvement or <180° interface between tumor and vessel wall of the portal vein and/or superior mesenteric vein (SMV-PV) and patent portal vein/splenic vein confluence. - For tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease. Borderline Resectable Pancreatic Cancer - Tumor-vessel interface ≥180° of vessel wall circumference, and/or reconstructible occlusion of the SMV-PV. - Tumor-vessel interface <180° of the circumference of the SMA. - Tumor-vessel interface <180° of the circumference of the celiac artery. - Reconstructible short-segment interface of any degree between tumor and hepatic artery.

10. Study of RP-6306 With FOLFIRI in Advanced Solid Tumors

    Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.