Profesionales médicos

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estado, etc.

1. Expanded Access Study For The Treatment Of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel

   Jacksonville, Fla., Rochester, Minn.

   The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

2. Natural History Evaluation Among Female Breast Cancer Survivors With Endocrine Therapy-Induced Alopecia

   Mankato, Minn., Rochester, Minn., Albert Lea, Minn.

   The purpose of this study is to learn about potential side effects facing people who are undergoing treatments for their cancer, specifically, hair loss. While this is not a well-documented side effect of hormone-blocking medications (such as tamoxifen, letrozole, anastrozole, or exemestane), we have preliminary evidence that it is a problem for some patients getting this treatment.  This study will include some patients receiving the hormone therapy and some patients who are not, so we can better understand whether patients getting the hormonal therapy have more hair loss than patients who are not getting such.

3. Phase I/​II Study Of [225Ac]Ac-PSMA-R2 In PSMA-positive Prostate Cancer, With/​Without Prior 177Lu-PSMA RLT

   Rochester, Minn.

   This is an open label, phase I/II, multi-center study in adult participants with metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration resistant prostate cancer (mCRPC) who have received prior anti-cancer treatment and have a positive 68Ga-PSMA-11 PET scan. The purpose of this study is to learn if the study drug, [225Ac]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients.

4. Testing The Addition Of An Anti-cancer Drug, Selinexor, To The Usual Chemotherapy Treatment (Temozolomide) For Brain Tumors That Have Returned After Previous Treatment

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

   The purpose of phase 1 of this trial is to determine the maximum tolerated dose of temozolomide followed by selinexor in recurrent glioblastoma patients as determined by dose-limiting toxicities [DLTs] and the total toxicity profile.

   The purpose of phase 2 of this trial is to evaluate the effectiveness of sequentially administering temozolomide and selinexor in recurrent glioblastoma as determined by progression-free survival [PFS].

5. Serum Derived From Patient Donors With Paraneoplastic Pemphigus (PNP) to Be Used as a Positive Control for PNP Test

   Rochester, Minn.

   The purpose of this study is to obtain serum from patients with certain rare immunobullous diseases (e.g., paraneoplastic pemphigus, laminin-332 pemphigoid) to replenish a source of positive control for our clinical testing (e.g., Mayo test codes PNPAB, RSBV).  

   • To verify the performance characteristics of anti-Paraneoplastic Pemphigus (PNP) serum and validate its use as a positive control in PNP test.  

   • Serum from patients with PNP will be used for a positive control for the PNP test upon successful validation. 

   Background:  

   For various rare immunobullous diseases, detection of a circulating autoantibody is necessary for accurate diagnosis. As a CLIA requirement, every clinical test run requires positive and negative controls for quality control.  Currently, we use either archived sera or commercially available sera from patients with known relevant immunobullous diseases as a structural integrity positive control of rat bladder or transfected cells, which are the substrates for these indirect immunofluorescence tests.  

   While we have no difficulty locating negative control sera, it is challenging to source positive control sera, due to the rarity of these diseases. Specifically, commercial positive control serum is no longer available for purchase and only limited archived material is available. 

6. Bladder Bank (A Prospective Banking Study)

   Rochester, Minn.

   The purpose of this study is to establish samples (blood and urine) to support the development of non-invasive tests for early detection of bladder cancer 

7. A Study Of The Drugs Selumetinib Vs. Carboplatin And Vincristine In Patients With Low-Grade Glioma

   Rochester, Minn.

   This study aims to demonstrate that the efficacy of treatment with selumetinib as measured by event-free survival (EFS) is non-inferior compared to treatment with carboplatin/vincristine (CV) in previously-untreated low-grade glioma (LGG) not associated with BRAFV600E mutations or systemic neurofibromatosis type 1 (NF1).

8. ORACLE: Observation Of ResiduAl Cancer With Liquid Biopsy Evaluation (ORACLE)

   Rochester, Minn.

   The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.

9. A Study Of 177Lu-FAP-2286 In Advanced Solid Tumors

   Jacksonville, Fla., Rochester, Minn.

   Fibroblast activation protein (FAP) is a cell surface protein that is highly expressed on the surface of cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of most epithelial cancers, whereas limited expression of FAP is observed in normal tissues. In some cancers of mesenchymal origin, notably sarcoma and mesothelioma, FAP expression has also been observed on the tumor cells themselves. Given the restricted expression profile, FAP is a promising target for peptide-targeted radionuclide imaging and therapeutic agents.
   
   Phase 1 of this study is designed to evaluate the safety and establish the recommended intravenous (IV) Phase 2 dose (RP2D) for \[177Lu\]Lu FAP 2286 monotherapy in participants with FAP expressing solid tumors.
   
   Phase 2 is designed to evaluate the safety and efficacy of \[177Lu\]Lu FAP 2286 as monotherapy in participants with pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and breast cancer (BC) and in combination with chemotherapy in participants with untreated PDAC or relapsed NSCLC.
   
   Participants in both Phase 1 and 2 will be selected for treatment with \[177Lu\]Lu FAP 2286 based on \[68Ga\]Ga FAP 2286 imaging for determining tumor FAP expression.

10. Leveraging Methylated DNA Markers (MDMs) In The Detection Of Endometrial Cancer And Cervical Cancer: A Phase II Clinical Study

    La Crosse, Wis., Rochester, Minn., Eau Claire, Wis., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma.