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Carboplatin as a Radiosensitizer in Treating Childhood Ependymoma

2014-08-27 03:15:10 | BioPortfolio

Summary

This is a phase II study evaluating the feasibility of concurrent carboplatin given with focal radiation therapy in children age 12 months to < 21 years with newly diagnosed localized ependymoma who have no or minimal residual disease post-operatively (< 0.5 cm). The hypothesis is that utilizing carboplatin as a radiosensitizer is feasible and tolerable and may improve event-free survival (EFS) and minimize local recurrences as compared to historic controls. Following a neurosurgical resection and staging, patients who meet the eligibility criteria will receive standard fractionated radiation therapy at doses of 54 to 59.4 Gy to the primary site depending upon age. All patients will receive 35 mg/m²/day of carboplatin prior to each fraction of radiotherapy. Although significant neutropenia is not anticipated, G-CSF will be administered per study guidelines during radiation if neutropenia occurs. All patients will be followed for toxicity, response (resolution of residual disease) and event-free survival (EFS). Patients' tumor sample, blood and cerebro-spinal fluid (CSF) will also be prospectively evaluated to quantify the level of Survivin, a known inhibitor of apoptosis, via immunohistochemistry, Western Blot Analysis (in tumor tissue) and ELISA (in blood and CSF). The feasibility of obtaining these levels prospectively and in real time will be evaluated.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Ependymoma

Intervention

Carboplatin

Location

Children's Memorial Hospital
Chicago
Illinois
United States
60614

Status

Recruiting

Source

Children's Memorial Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:10-0400

Clinical Trials [793 Associated Clinical Trials listed on BioPortfolio]

Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy

RATIONALE: Gathering information about how young patients with ependymoma respond to standard combination chemotherapy and learning about the long-term effects of this treatment may help d...

Outcomes and Risk in People With Ependymoma

Background: Ependymoma is a rare type of primary brain or spine tumor. That means that it starts in the brain or spine. These tumors affect both children and adults. Researchers want to s...

Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells o...

LET Optimized IMPT in Treating Pediatric Patients With Ependymoma

This phase I trial studies the side effects of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) in treating pediatric patients with ependymoma. Radiation therap...

Everolimus for Children With Recurrent or Progressive Ependymoma

The purpose of this study is to evaluate the anti-tumor activity of Everolimus among children with recurrent or progressive ependymoma. Recurrent or progressive ependymoma is incurable and...

PubMed Articles [92 Associated PubMed Articles listed on BioPortfolio]

Population pharmacokinetics of carboplatin, etoposide and melphalan in children: A re-evaluation of paediatric dosing formulas for carboplatin in patients with normal or mild impairment of renal function.

Carboplatin is dosed by the glomerular filtration rate (GFR) to achieve target plasma area under the curve (AUC). The aims of this study were to investigate factors that influence the pharmacokinetics...

A Mouse Ependymoma Model Provides Molecular Insights into Tumor Formation.

Ozawa et al. present a murine tumor model resembling the most frequent molecular group of human supratentorial ependymoma, ST-EPN-RELA. Their model shows RELA-fusion-based de novo ependymoma tumorige...

Experimental animal study of docetaxel combined with carboplatin in the treatment of retinoblastoma.

The synergistic effects of docetaxel (DTX) combined with carboplatin in the treatment of retinoblastoma (RB) was explored in mouse RB xenografts compared with carboplatin alone and DTX alone groups. R...

Microsurgical Resection of Anaplastic Ependymoma of the Cerebellopontine Angle in an Adult: 3-Dimensional Operative Video.

Infratentorial ependymomas usually arise in the fourth ventricle and extend into the cerebellopontine angle (CPA) through the foramina of Luschka is well described. A primary CPA location of an ependy...

The FoxM1-ABCC4 axis mediates carboplatin resistance in human retinoblastoma Y-79 cells.

Carboplatin is the most commonly used drug in the first-line treatment of human retinoblastoma (RB), but its clinical application is greatly limited due to acquired drug resistance upon the long-term ...

Medical and Biotech [MESH] Definitions

An organoplatinum compound that possesses antineoplastic activity.

Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21)

Benign and malignant intra-axial tumors of the MESENCEPHALON; PONS; or MEDULLA OBLONGATA of the BRAIN STEM. Primary and metastatic neoplasms may occur in this location. Clinical features include ATAXIA, cranial neuropathies (see CRANIAL NERVE DISEASES), NAUSEA, hemiparesis (see HEMIPLEGIA), and quadriparesis. Primary brain stem neoplasms are more frequent in children. Histologic subtypes include GLIOMA; HEMANGIOBLASTOMA; GANGLIOGLIOMA; and EPENDYMOMA.

Benign and malignant neoplasms which occur within the substance of the spinal cord (intramedullary neoplasms) or in the space between the dura and spinal cord (intradural extramedullary neoplasms). The majority of intramedullary spinal tumors are primary CNS neoplasms including ASTROCYTOMA; EPENDYMOMA; and LIPOMA. Intramedullary neoplasms are often associated with SYRINGOMYELIA. The most frequent histologic types of intradural-extramedullary tumors are MENINGIOMA and NEUROFIBROMA.

Glioma derived from ependymocytes that tend to present as malignant intracranial tumors in children and as benign intraspinal neoplasms in adults. It may arise from any level of the ventricular system or central canal of the spinal cord. Intracranial ependymomas most frequently originate in the FOURTH VENTRICLE and histologically are densely cellular tumors which may contain ependymal tubules and perivascular pseudorosettes. Spinal ependymomas are usually benign papillary or myxopapillary tumors. (From DeVita et al., Principles and Practice of Oncology, 5th ed, p2018; Escourolle et al., Manual of Basic Neuropathology, 2nd ed, pp28-9)

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