Oncología (médica)

A continuación, se enumeran los ensayos clínicos actuales.

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

1. A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection

   Jacksonville, Fla.

   The purpose of this study is to compare the drug levels of nivolumab administered subcutaneously versus intravenous administration in participants with melanoma following complete resection.

2. Study of Tumor-treating Fields to Treat Leptomeningeal Metastases from Breast Carcinoma Involving the Spine

   Jacksonville, Fla.

   The purpose of this study is to evaluate the safety and feasibility of the spinal array in treatment of patients with leptomeningeal metastases within the spine

   The median survival of patients with LM with treatment is generally less than 5 months. There are four FDA-approved drugs for intra-CSF use in LM, but all have shown limited activity with no clear increase in survival outcome with treatment. Intra-CSF treatment is also invasive, involving either surgical placement of an intraventricular reservoir, or treatment (intrathecal) via repetitive lumbar punctures, and there is risk of adverse events including vomiting, headache, arachnoiditis and leukoencephalopathy with treatment. Systemic chemotherapy, targeted agents and immunotherapy have largely been ineffective in treatment of LM, in part due to limited CNS/CSF penetration. New effective treatments are needed.

   TTF represents a new modality that is well tolerated with minimal adverse events. TTF has not produced significant additive toxicity when combined with systemic treatments. In addition, no invasive procedures are required, and treatment has been administered for long term without apparent cumulative toxicities.  TTF is currently approved for treatment of glioblastoma and mesothelioma. TTF is currently under study for treatment of CNS parenchymal metastases, lung and pancreatic cancer. There is potential application for symptomatic treatment of LM and intradural, extradural and vertebral metastases. Given the lack of effective therapies for LM, TTF is a promising alternative modality that should be explored. In addition, the lack of overlapping toxicities would potentially allow the use of TTFields in conjunction with other ongoing treatments for the leptomeningeal or systemic cancer. For these reasons, we are proposing an exploratory, phase I feasibility study of TTFields in treatment of the spinal component of leptomeningeal metastases, If feasible, consideration will be given to expansion to a Phase 1/2 study in a selected cohort of patient with LM.  

3. Patient Adherence and Symptoms During Post-operative Fluid Restriction Protocol After Transsphenoidal Surgery

   Jacksonville, Fla.

   The objectives of this study are to survey patients during the post-operative period regarding their experience with fluid restriction including adherence and discomfort, and to document rates of hyponatremia and readmissions in post-operative patients.

   Advances in endonasal, endoscopic transsphenoidal surgical techniques have decreased complications and length of stay for persons undergoing resection of sellar and suprasellar masses  Previous research by investigators now at Mayo (SLS, AQH) has shown that particular interventions including fluid restriction post-operatively decrease patient morbidity (e.g., from hyponatremia) and readmissions while maintaining patient safety. However, the patient perspective on the impact of fluid restriction has not been documented.

    

4. Prehabilitation

   Rochester, Minn.

   Physical activity plays an important role in reducing the adverse effects of cancer treatment. There are few studies using prehabilitation to improve peri-operative outcomes in patients undergoing cancer surgery. This study will pilot a program of structured activity for women undergoing neoadjuvant chemotherapy with the intent to improve their physical state prior to surgical intervention and thus improve outcomes.

   It has been shown that patients with advanced ovarian cancer may suffer from high levels of cancer –specific distress, depression and anxiety. It has also been proposed that psychological resilience can favorably affect psychological and treatment-related outcomes in cancer patients. Most current studied mindfulness-based interventions are limited by the time commitment required by the patient, which is difficult for patients with advanced cancer undergoing treatment, therefore we have created a virtual program that is more easily accessible by patients. 

   Frailty is thought to be mediated by senescent cells and their dynamic secretome, referred to as the senescence-associated secretory phenotype (SASP). Senescent cells contribute to age-related tissue deterioration, inflammation, and fibrosis. A group of novel frailty biomarkers obtained at the time of diagnosis has been examined in advanced OC patients. Preliminary data show that these biomarkers strongly correlate with the clinical frailty phenotype, and define a frail subgroup of patients with higher treatment related morbidity and worse survival. These markers may represent important surrogate clinical trial endpoints, as well as deepen the understanding of aging in women with ovarian cancer. In this pilot, these markers and other surrogate endpoints for future novel translational research in the science of aging will be explored. 

    

5. A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients with Recurrent Glioblastoma with Elevated Mutational Burden

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

   The purpose of this study is to evaluate the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioblastoma that has come back (recurrent) and carries a high number of mutations. Cancer is caused by changes (mutations) to genes that control the way cells function. Tumors with high number of mutations may respond well to immunotherapy. Immunotherapy with monoclonal antibodies such as ipilimumab and nivolumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving ipilimumab and nivolumab may lower the chance of recurrent glioblastoma with high number of mutations from growing or spreading compared to usual care (surgery or chemotherapy).

6. A Study to Explore Tumor Biology in Metastatic Esophageal and Gastric Cancer Patients

   Rochester, Minn.

   The purpose of this study is to explore various biomarkers in the post-treatment tissue of patients who have responded to cancer therapy and compare it to the biopsy performed prior to cancer treatment.

7. A Study to Assess Endometrial Cancer Recurrence in Patients After 36 Months

   Rochester, Minn.

   The purpose of this study is to assess the 36-month incidence of pelvic/non-vaginal recurrence among patients with surgical stage I intermediate-risk endometrial cancer.

   Eligible patients presenting with apparent uterine confined grade 1, 2, or 3 endometrioid endometrial cancer will undergo standard-of-care primary surgical treatment with a cervical injection of indocyanine green (ICG) dye for SLN mapping, a total hysterectomy, removal of the adnexae and staging with sentinel node mapping and pelvic washings. 

   The final assessment for inclusion in the follow-up part of the study will be determined from the results of the final hysterectomy and staging pathology report to ensure bilaterally negative pelvic sentinel nodes and a surgical stage I endometrioid endometrial cancer grade 1 or 2 with 50% or more uterine myoinvasion or grade 3 with less than 50% uterine myoinvasion. Women meeting this criteria will comprise the study cohort and be followed for three years.   

    

8. A Study to Evaluate the Safety and Tolerability of HMPL-306 to Treat Advanced or Metastatic Solid Tumors with IDH Mutations

   Rochester, Minn.

   The purpose of this study is to evaluate the safety, tolerability, and preliminary effectiveness of HMPL-306 in advanced or metastatic solid tumors with IDH mutation.

9. Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

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

   This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Subjects who received at least one GM T cell infusion, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

10. Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer

    Rochester, Minn.

    The purpose of this study is to answer whether plasma circulating tumor DNA (ctDNA) obtained by serial analysis before, during, and following surgery, radiotherapy, chemotherapy, and/or immunotherapy for cervical cancer will allow for risk stratification, individualized treatment decision making, monitoring of treatment response, and early detection of residual or recurrent disease in patients presenting with human papillomavirus (HPV) mediated cervical cancer.