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. 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.

4. 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.   

    

5. 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.

6. 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.

7. Testicular Tissue Cryopreservation in Children

   Rochester, Minn.

   This protocol is being designed to offer testicular tissue cryopreservation to male pediatric patients (0-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential.

8. A Study to Develop and Maintain a Registry of Specimens from Patients with Bladder Cancer

   Jacksonville, Fla.

   The purpose of this study is to develop and maintain a registry of blood and urine specimens of patients who have been treated for bladder cancer.

9. A Study to Evaluate Regional Radiotherapy in Biomarker Low-Risk Node Positive Breast Cancer

   Jacksonville, Fla.

   The purpose of this study is to compare the effects on low-risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.

10. A Study to Evaluate the Safety, Tolerability, and Determine the Optimal Dose for the Expansion Cohorts of VSV-IFNβ-NIS in Combination with Pembrolizumab in Patients with Refractory Solid Tumors

    Rochester, Minn.

    The purpose of this study is to determine the safety of VSV-IFNβ-NIS in combination with pembrolizumab, followed by expansion to examine effectiveness of combination therapy in patients with refractory Non-Small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC).