Neoplasms

All Conditions

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Glioma

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Neuroblastoma

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Liver Neoplasms

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Neuroectodermal Tumors, Primitive, Peripheral

Ependymoma

Craniopharyngioma

Adamantinoma

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Rhabdoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Sarcoma, Clear Cell

Neoplasms, Neuroepithelial

Choroid Plexus Neoplasms

Ameloblastoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Myosarcoma

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Bone Neoplasms

Bone Diseases

Cerebral Ventricle Neoplasms

Brain Neoplasms

Brain Diseases

Central Nervous System Diseases

Renal Cell Carcinoma

Soft Tissue Sarcoma

Clear Cell Renal Cell Carcinoma

Germ Cells Tumors

Wilms' Tumor

Ewing Sarcoma

Neuroepithelioma

Dysembryoplastic Neuroepithelial Tumor

A total of 200 neuroblastoma, brain tumor, and rare tumor patients will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).

Guided Therapy

Giselle Sholler, MD

The purpose of this study is to test the feasibility (ability to be done) of experimental technologies to determine a tumor's molecular makeup. This technology includes a genomic report based on DNA exomes and RNA sequencing that will be used to discover new ways to understand cancers and potentially predict the best treatments for patients with cancer in the future.

Molecular-Guided Therapy for Childhood Cancer

Molecular-guided Therapy for the Treatment of Patients With Relapsed and Refractory Childhood Cancers

The definition of feasibility is: Enrollment onto study, genomic profile, analysis and report generation completed, tumor board held with treatment decision, treatment review completed, start of treatment, and completion of 1 cycle of therapy.

To determine the safety of allowing a molecular tumor board to determine individualized treatment plans

To determine the activity of treatments chosen based on Overall response rate (ORR) using RESIST criteria. The assessment of response will include the initial measurable targets and will be performed after cycle 2, then after every other cycle. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI imaging and/or by MIBG or PET scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, At least a 20% increase in the sum of the disease measurements for measurable lesions, Stable Disease, Neither sufficient decrease to qualify for PR or sufficient increase to qualify for PD from study entry. Overall Response (OR) = CR + PR.

Time to progression (PFS), defined as the period from the start of the treatment until the criteria for progression are met taking as reference the screening measurements. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment (nadir), and minimum 5 mm increase over the nadir or the appearance of one or more new lesions or appearance of positive bone marrow.

Translational Genomics Research Institute

Dell, Inc.

Giselle Sholler

Study Chair

A total of 200 neuroblastoma, brain tumor, and rare tumor patients will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).

Guided Therapy: A total of 200 neuroblastoma, brain tumor, and rare tumor patients will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Tumor Type

Subjects that started at least one dose of study therapy

Subjects on study with a diagnosis of Neuroblastoma

Subjects on study with a diagnosis of a CNS Tumor which included, but was not limited to, Ependymoma, Glioblastoma, Diffuse Midline Glioma, and Other CNS Tumors.

CNS Tumors

Subjects on study with a diagnosis of a rare solid tumor which included, but was not limited to, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma, and Other Rare Tumors.

Rare Tumors

Days to Treatment Will be Used in Order to Determine Feasibility of Using Tumor Samples to Assess Genomic Sequencing Using Predictive Modeling to Make Real-time Treatment Decisions for Children With Relapsed/Refractory Cancers.

All subjects that received at least one dose of study therapy.

Number of Participants With an Unexpected Adverse Events as a Measure of Safety

Complete Response

No Evidence of Disease

Partial Response

Stable Disease

Progressive Disease

Having at least one disease evaluation following completion of at least one cycle of molecular-guided therapy

Overall Response Rate (ORR) of Participants by the Presence of Radiologically Assessable Disease by Cross-sectional CT or MRI Imaging and/or by MIBG or PET Scans.

Time on study was measured in days from the date of initial biopsy to date of last administration of study therapy. For subjects with \>1 biopsies and \>1 MGT regimens, the off-therapy date from their last treatment was used.

Progression Free Survival (PFS) Interval Will be Measured by Days and Compared to the PFS of Previous Chemotherapy Regimens Since Relapse for Each Patient.

Overall Study

Ganglioglioma

Pierre-Jean LE RESTE, Md

One of the key issues of tumour brain surgeries is to clearly define the borders of the tumor. The investigators proposed to evaluate the feasibility of intraoperative fluorescein guidance. Patients will be identified from the list of patients operated on under fluorescence to collect clinical datas. Surgical videos will be analyzed to assess the presence of intraoperative fluorescence and its subjectively judged intensity. MRI data will be extracted from the radiological reports to assess quality extraction. No additional data will be produced

Gangliogliomas typically present as a slow-growing, cystic mass taking contrast, while dysembryoplastic neuro-epithelial tumors commonly show microcystic patterns, inconstant contrast-enhancement and are preferentially located on the internal face of the temporal lobe. The cornerstone of the treatment of these two entities remains surgery, as it provides good oncological outcomes and control of seizures. Surgical resection keeps a major role for these tumors. Thus, one of the key issues is to clearly define the borders of the tumor during surgery, a point of considerable importance for these curable lesions. Then, the investigators proposed to evaluate the feasibility of intraoperative fluorescein guidance, a technique based on the staining of blood-brain barrier breakdown areas with fluorescein. Patients will be identified from the list of patients operated on under fluorescence maintained by the department since the acquisition of the technique. Clinical datas will be collected and surgical videos will be analyzed to assess the presence of intraoperative fluorescence and its subjectively judged intensity (absent, weak, medium, strong). MRI data (quality of excision: total, subtotal or partial according to usual criteria) will be extracted from the radiological reports. No additional data will be produced

Intraoperative Fluorescence of Ganglogliomas and Neuroepithelial Dysembryoplastic Tumors

Intraoperative Fluorescence of Gangliogliomas and Neuroepithelial Dysembryoplastic Tumors

Number of patients which present intraoperative tumor fluorescence. Fluorescence will be assessed using surgical videos.

Number of allergic events during fluorescein-based surgery

Percentage of excised tumour volume. Quality of excision on the post-operative MRI control according to the volume of the remaining pathological contrast intake (complete, subtotal or partial)

Occurence of postoperative epilepsy events using Engels classification. (Class I: Free of disabling seizures, Class II: Rare disabling seizures ("almost seizure-free"), Class III: Worthwhile improvement, Class IV: No worthwhile improvement)

Rennes University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Molecular-Guided Therapy for Childhood Cancer	NCT02162732	Neuroblastoma Medulloblastoma Glioma Ependymoma Choroid Plexus ... Craniopharyngio... Dysembryoplasti... Meningioma Primitive Neuro... Germ Cell Tumor... Rhabdomyosarcom... Non-rhabdomyosa... Ewings Sarcoma Osteosarcoma Wilms Tumor Renal Cell Carc... Malignant Rhabd... Clear Cell Sarc... Liver Tumors	Guided Therapy	13 Months - 21 Years	Milton S. Hershey Medical Center
Intraoperative Fluorescence of Ganglogliomas and Neuroepithelial Dysembryoplastic Tumors	NCT03970785	Surgical Proced...		18 Years -	Rennes University Hospital

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