肿瘤科（内科）

以下为当前的临床试验。

按位置、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. (Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer

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

   The purpose of this study is to identify a (Z)-endoxifen dose that achieves (Z)-endoxifen steady-state plasma concentrations (Css) between 500-1000 ng/mL. Dosing will begin with the (Z)-endoxifen 40 mg/day dose and may additionally explore either a lower (20 mg/day) or higher (80 mg/day) dose level based on (Z)-endoxifen Css as well as toxicity.

3. A Study Of Radiation Dosimetry, Safety, And Tolerability Of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment In Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study

   Rochester, Minn.

   The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).

4. Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer

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

   The purpose of this study is to identify the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding abemaciclib to olaparib may work better to treat recurrent platinum-resistant ovarian cancer.

5. 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.

6. MElanoma Research Lymph node prediction Implementation National_001 (MERLIN_001)

   Rochester, Minn.

   This study aims to create a registry for primary melanoma gene-signature to predict sentinel node (SN) status and determine its prognostic value for more accurate staging of SN-negative melanoma patients.

7. PLX038 for the Treatment of Metastatic Ovarian, Peritoneal, and Fallopian Tube Cancers

   Rochester, Minn.

   The purpose of this study is to determine the response rate to PLX-038 in patients with metastatic ovarian, primary peritoneal, and fallopian tube cancers that are resistant to platinum drugs.

8. Interviews About Social Determinants of Health in Southeast Asian Americans to Identify Liver Cancer Disparities

   Rochester, Minn.

   This study is intended to understand the experiences and barriers to cancer care for individuals diagnosed with liver or any other type of cancer. Individual interviews will be conducted. 

9. 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®.

10. 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.