NCT02724579|Active Not RecruitingPhase 2FDA Device

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

A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

Children's Oncology Group ClinicalTrials.gov

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3 other identifiers

ACNS1422NCI-2016-00150U10CA180886

Study Type

interventional

Target

Locations

5 countries

Sites

195

Timeline

RegisteredMar 2016

StartedNov 2017

CompletionMar 2028

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

23mo left

Started Nov 2017

Longer than P75 for phase_2

Geographic Reach

5 countries

195 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.4 years study duration

Study Progress82%

Nov 2017Mar 2028

First Submitted

Initial submission to the registry

March 25, 2016

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed

1.6 years until next milestone

Study Start

First participant enrolled

November 17, 2017

Completed

10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

May 5, 2026

Status Verified

February 1, 2026

Enrollment Period

10.4 years

First QC Date

March 25, 2016

Last Update Submit

May 1, 2026

Conditions

Medulloblastoma

Outcome Measures

Primary Outcomes (1)

Progression-free survival (PFS)
PFS along with the confidence intervals will be estimated using the Kaplan-Meier method. PFS will also be reported based on central radiology review.
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

Secondary Outcomes (2)

Deoxyribonucleic acid (DNA) methylation profiling as real-time classification of WNT-driven medulloblastoma
Within 32 days of definitive surgery
Change in neurocognitive function (cognitive, social, emotional and behavioral) according to Children Oncology Group Standard Neuropsychological Battery
Baseline to up to 60 months post-diagnosis

Other Outcomes (2)

DNA methylation profiling of medulloblastoma real-time" predictive classification scheme for the SHH, group 3 and group 4 medulloblastoma subgroups according to the Heidelberg classifier
Within 32 days of definitive surgery
Audiologic and endocrinologic toxicities
Up to 10 years

Study Arms (1)

Treatment (reduced radiation therapy and chemotherapy)

EXPERIMENTAL

RADIATION THERAPY: Beginning 4-5 weeks after surgery, patients undergo craniospinal radiation therapy 5 days a week for 6 weeks. MAINTENANCE THERAPY (WEEKS 1, 3, 5, and 7): Beginning 4-6 weeks after completion of radiation therapy patients receive lomustine PO on day 1, vincristine sulfate IV over 1 minute or via minibag on days 1, 8, and 15, and cisplatin IV over 6 hours on day 1. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY (WEEKS 2, 4, AND 6): Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 2, mesna IV over 15-30 minutes on days 1 and 2, and vincristine sulfate IV over 1 minute or via minibag on days 1 and 8. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial.

Drug: CisplatinDrug: CyclophosphamideOther: Laboratory Biomarker AnalysisDrug: LomustineProcedure: Magnetic Resonance ImagingRadiation: Radiation TherapyDrug: VincristineDrug: Vincristine Sulfate

Interventions

CisplatinDRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin