Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Active, not recruiting Phase 2

Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma

NCT02724579 · tracked via the Priya Life Science Australia tracker
Phase
Phase 2
Started
2017-11-17
Last updated
2026-07-16

Condition(s) studied

Medulloblastoma

Investigational drug(s) / intervention(s)

Cisplatin →Cyclophosphamide →Laboratory Biomarker AnalysisLomustine →Magnetic Resonance ImagingRadiation TherapyVincristine →Vincristine Sulfate →

Cisplatin: Given IV

Cyclophosphamide: Given IV

Laboratory Biomarker Analysis: Correlative studies

Lomustine: Given PO

Magnetic Resonance Imaging: Undergo MRI

Radiation Therapy: Undergo craniospinal radiation therapy

Vincristine: Given IV or via minibag

Vincristine Sulfate: Given IV or via minibag

Study summary

This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.

Eligibility

Sex
ALL
Min age
3 Years
Max age
21 Years
Healthy volunteers
No
Inclusion Criteria: * Patients must be greater than or equal to 3 years and less than 22 years of age at the time of enrollment * Patients must be newly diagnosed and have: * Eligibility confirmed by rapid central pathology and molecular screening review on APEC14B1: * Classical histologic type (non LC/A) WNT medulloblastoma * Positive nuclear beta-catenin by immunohistochemistry (IHC) * Positive for CTNNB1 mutation by Sanger sequencing * Negative for MYC and MYCN by fluorescence in situ hybridization (FISH) * Patient must have negative lumbar cerebrospinal fluid (CSF) cytology * Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study; patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status; patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated; patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively * Patients must have eligibility confirmed by Rapid Central Imaging Review on APEC14B1; patients must have =\< 1.5 cm\^2 maximal cross-sectional area of residual tumor; whole brain magnetic resonance imaging (MRI) with and without gadolinium and spine MRI with gadolinium must be performed * Patients must be enrolled, and protocol therapy must be projected to begin, no later than 36 days after definitive diagnostic surgery (day 0) * Peripheral absolute neutrophil count (ANC) \>= 1000/uL * Platelet count \>= 100,000/uL (transfusion independent) * Hemoglobin \>= 8.0 g/dL (may receive red blood cell \[RBC\] transfusions) * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows: * 3 to \< 6 years of age: maximum (max) serum creatinine 0.8 mg/dL (males and females) * 6 to \< 10 years of age: max serum creatinine 1 mg/dL (males and females) * 10 to \< 13 years of age: max serum creatinine 1.2 mg/dL (males and females) * 13 to \< 16 years of age: max serum creatinine 1.5 md/dL (males) and 1.4 md/dL (females) * \>= 16 years of age: max serum creatinine 1.7 mg/dL (males) and 1.4 mg/dL (females) * The threshold creatinine values were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC) * Total or direct bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and * Serum glutamate pyruvate (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (3x ULN); for the purpose of this study, the ULN for SGPT is 45 U/L * Central nervous system function defined as: * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled * Patients must not be in status epilepticus, a coma or on assisted ventilation at the time of study enrollment * Patients must have receptive and expressive language skills in English, French, or Spanish to complete the QoL and neurocognitive assessments; if a patient meets these criteria but the parent/guardian speaks a language other than English, French, or Spanish, the patient may still be enrolled and tested, and the parent-report measures should be omitted * All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: * Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology are not eligible; patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible * Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids * Pregnancy and Breast Feeding * Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies * Lactating females are not eligible unless they have agreed not to breastfeed their infants * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained * Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation * Patients with a history of moderate to profound intellectual disability (i.e., intelligence quotient \[Q)\]=\< 55) are not eligible for enrollment; PLEASE NOTE: Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g., dyslexia) are eligible for this study. Children with posterior fossa syndrome (also known as cerebellar mutism) are eligible for this study

Primary outcome measure(s)

  • Progression-free survival (PFS) — From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 10 years
    PFS along with the confidence intervals will be estimated using the Kaplan-Meier method. PFS will also be reported based on central radiology review.

Trial sites (195)

FacilityCityRegionStatus
Children's Hospital of Alabama Birmingham Alabama
USA Health Strada Patient Care Center Mobile Alabama
Providence Alaska Medical Center Anchorage Alaska
Banner Children's at Desert Mesa Arizona
Phoenix Childrens Hospital Phoenix Arizona
Arkansas Children's Hospital Little Rock Arkansas
Kaiser Permanente Downey Medical Center Downey California
Loma Linda University Medical Center Loma Linda California
Miller Children's and Women's Hospital Long Beach Long Beach California
Children's Hospital Los Angeles Los Angeles California
Cedars-Sinai Medical Center Los Angeles California
Mattel Children's Hospital UCLA Los Angeles California
Valley Children's Hospital Madera California
UCSF Benioff Children's Hospital Oakland Oakland California
Kaiser Permanente-Oakland Oakland California
Children's Hospital of Orange County Orange California
Lucile Packard Children's Hospital Stanford University Palo Alto California
Sutter Medical Center Sacramento Sacramento California
University of California Davis Comprehensive Cancer Center Sacramento California
Rady Children's Hospital - San Diego San Diego California
UCSF Medical Center-Mission Bay San Francisco California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
Children's Hospital Colorado Aurora Colorado
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado
Connecticut Children's Medical Center Hartford Connecticut
Alfred I duPont Hospital for Children Wilmington Delaware
MedStar Georgetown University Hospital Washington D.C. District of Columbia
Golisano Children's Hospital of Southwest Florida Fort Myers Florida
UF Health Cancer Institute - Gainesville Gainesville Florida
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida
Nemours Children's Clinic-Jacksonville Jacksonville Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
Nicklaus Children's Hospital Miami Florida
AdventHealth Orlando Orlando Florida
Arnold Palmer Hospital for Children Orlando Florida
Nemours Children's Hospital Orlando Florida
Nemours Children's Clinic - Pensacola Pensacola Florida
Sacred Heart Hospital Pensacola Florida
Johns Hopkins All Children's Hospital St. Petersburg Florida
Tampa General Hospital Tampa Florida

+ 155 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02724579 on ClinicalTrials.gov ↗ ← All trials in Australia