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. Innovative CAR-TIL immunotherapy against melanoma

   Jacksonville, Fla.

   The chimeric antigen receptor (CAR) T-cell therapy is a revolutionary cellular immunotherapy strategy that has transformed the treatment of B cell malignancies by engineering T cells to recognize B cell specific tumor markers; however, attempts to treat solid tumors with CAR T-cells have identified unique challenges that have rendered CAR T cells less effective against these tumors. Conventional CARs are designed to target tumor-associated antigens, but antigenic heterogeneity and the variable nature of surface antigen expression provide escape mechanisms for solid tumors from CAR T-cell attack. [1, 2] The solid tumor stroma acts as an immunosuppressive cloud that impedes the homing of peripheral CAR T-cells into the tumor microenvironment (TME). The hostile TME can also drive CAR T-cells to functional exhaustion and metabolic dysfunction, thus blunting the therapeutic efficacy of CAR T-cells.[3] Oncolytic viruses or radiation that generate local inflammation in the TME have been shown to promote T cell homing and infiltration [4] but do not address the exhaustion of tumor infiltrating lymphocytes (TILs). The PD-1/PD-L1 cascade allows tumors to evade the immune system by suppressing T cell function within the TME. [5, 6] An ideal adoptive cellular therapy must possess the ability to not only return to the site of the tumor but must also retain cytotoxic potential after a recognition event. We present here a CAR design that allows PD-1 to recognize PD-L1 on the tumor; however, the intracellular CAR design is one that results in T cell activation as opposed to inhibition. We hypothesize that targeting melanoma with a PD-1 (MC9324) CAR TIL therapy would capitalize on the tumor homing machinery of the TIL to drive the CAR TIL to the tumor where engagement of the PD-1 domain of the CAR with PD-L1 on the tumor cell would result in T cell cytotoxic killing.

2. Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies

   Rochester, Minn.

   This clinical trial is studying long-term follow-up in patients who are or have participated in Children's Oncology Group studies. Developing a way to track patients enrolled in Children's Oncology Group studies will help doctors gather long-term follow-up information and may help the study of cancer in the future.

3. A Study to Provide Access to CTL019 Out of Specification Managed Access Program (MAP) for ALL or DLBCL Patients

   Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to provide access to CTL019 through Managed Access Program (MAP) for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

4. A Study to Evaluate Outpatient Blinatumomab in Subjects with Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)

   Jacksonville, Fla.

   The purpose of this study is to determine the safety and feasibility of complete outpatient blinatumomab administration for subjects with minimal residual disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL).

    

    

5. Immune Response to Antigens

   Jacksonville, Fla.

   The purpose of this study is to sequence patient germline and tumor samples, and nominate top neoantigen candidates using an in-house developed bioinformatics pipeline, and to validate the neoantigen candidates by laboratory assays using patient peripheral blood immune cells or serum.

6. Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (Pap-Op): Prospective Assessment of HPV Associated Anogenital Pathology

   Rochester, Minn.

   The purpose of this study is to determine the incidence of anogenital infection with high-risk HPV serotypes and HPV-associated anogenital lesions in female patients with newly diagnosed HPV(+)OPSCC and female partners of patients with HPV(+)OPSCC, and compare this with retrospective review of exams and paps obtained during routine well woman checks in Rochester MN.  

7. Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial

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

   The purpose of this study is to estimate the rate of sustained MRD negativity (MRD negative status at any point, with a repeated MRD negative status one year later) in subjects with high-risk multiple myeloma.

8. International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)

   Rochester, Minn.

   This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions. InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments: A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND). After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either: P. prophylactic PLND Q. no prophylactic PLND

9. Establishment of Preclinical Models from Patients with Gynecological Malignancies

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   Effective treatments for recurrent gynecological cancer are lacking, and there is a need for novel therapeutic options. One of the barriers to improving outcomes in this subgroup of patients is the paucity of tumor models that can mimic patient characteristics to study novel therapies. Patient-derived xenograft (PDX) models are considerate the most representative pre-clinical model of human cancer, recapitulating the key characteristics of the original patient tumor. Other preclincal models to test drug effcicacy includes ex vivo 3D culture and 2D culture systems. In this study, we make and test preclinical models of gynecological cancers (ovarian, fallopian tube, peritoneal, uterine, vulvar, cervix, and vaginal) of any histologic subtype using surplus tumor specimens obtained at the time of routine tumor biopsy procedure, or clinically-indicated surgery.

10. Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer

    Rochester, Minn.

    99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active surveillance and are undergoing voluntary radical prostatectomy (RP) [Cohort A] or routine prostate biopsy [Cohort B]. This Phase 3 study is designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 SPECT/CT imaging to correctly identify subjects with previously unknown clinically significant prostate cancer.