MedTrace Logo

Study Assessing the Feasibility of a Surgery and Chemotherapy-Only in Children With Wnt Positive Medulloblastoma

NCT02212574 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-11-05

Study results available
· View outcomes & findings →

Summary

Participants enrolling on this study will receive standard of care chemotherapy for Wnt positive medulloblastoma without the radiation therapy or the weekly chemotherapy that is given during radiation therapy.

Conditions

Interventions

DRUG

Lomustine

Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1.

DRUG

Vincristine

Chemotherapy Cycle A Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15.

DRUG

Cisplatin

Chemotherapy Cycle A Cisplatin is given directly into a vein over 8 hours on Day 1.

DRUG

Cyclophosphamide

Chemotherapy Cycle B Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2.

DRUG

Mesna

Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours.

DRUG

Vincristine

Chemotherapy Cycle B Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8.

Sponsors & Collaborators

  • The Matthew Larson Foundation for Pediatric Brain Tumors

    collaborator OTHER

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Kenneth Cohen, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-04
Primary Completion
2018-11-09
Completion
2018-11-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02212574 on ClinicalTrials.gov