Cyclophosphamide for Medulloblastoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
MedulloblastomaCyclophosphamide - Drug
Eligibility
3 - 21
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing how well reduced doses of radiation therapy to the brain and spine, plus chemotherapy, work in treating patients with a certain type of brain tumor.

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 10 years

Month 60
Body Weight Changes
Year 10
Progression-free survival (PFS)
Up to 10 years
Audiologic and endocrinologic toxicities
Day 32
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
Deoxyribonucleic acid (DNA) methylation profiling as real-time classification of WNT-driven medulloblastoma

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (reduced radiation therapy and chemotherapy)
1 of 1

Experimental Treatment

45 Total Participants · 1 Treatment Group

Primary Treatment: Cyclophosphamide · No Placebo Group · Phase 2

Treatment (reduced radiation therapy and chemotherapy)Experimental Group · 7 Interventions: Cisplatin, Cyclophosphamide, Laboratory Biomarker Analysis, Vincristine, Lomustine, Vincristine Sulfate, Radiation Therapy · Intervention Types: Drug, Drug, Other, Drug, Drug, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platinum
Not yet FDA approved
Cyclophosphamide
FDA approved
Vincristine
FDA approved
Lomustine
FDA approved
Vincristine
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,128,832 Total Patients Enrolled
85 Trials studying Medulloblastoma
9,964 Patients Enrolled for Medulloblastoma
Children's Oncology GroupLead Sponsor
448 Previous Clinical Trials
236,465 Total Patients Enrolled
17 Trials studying Medulloblastoma
3,715 Patients Enrolled for Medulloblastoma
Nicholas J GottardoPrincipal InvestigatorChildren's Oncology Group

Eligibility Criteria

Age 3 - 21 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a positive result for MYC or MYCN by FISH.
You have medulloblastoma that is classical histologic type.
You have a positive test result for CTNNB1 mutation.
Patient must have negative CSF cytology.
Patients must have eligibility confirmed by Rapid Central Imaging Review on APEC14B1; patients must have =< 1.