NCT02212574

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

Pilot Study Assessing the Feasibility of a Surgery and Chemotherapy-Only Approach in the Upfront Therapy of Children With Wnt Positive Standard Risk Medulloblastoma

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There will be 9 cycles of chemotherapy. There are two different kinds of cycles given. They are referred to as A and B. Cycle A lasts for 6 weeks and Cycle B lasts for 4 weeks. B cycles are given after the completion of two A cycles. Below are the details of the drugs and schedules for A and B cycles. Cycle A (This cycle lasts 42 days) * Lomustine (CCNU) is given by mouth on Day 1. * 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. * Cisplatin is given directly into a vein over 8 hours on Day 1 Cycle B (This cycle lasts 28 days) * Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2. * 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. * 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. You may also get a supportive care drug called a myeloid growth factor (filgrastim or pegfilgrastim). This drug will help your blood counts recover after the chemotherapy is given.

Conditions

• Medulloblastoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-04
• Primary completion: 2018-11-09
• Completion: 2018-11-09
• First posted: 2014-08-08
• Last updated: 2021-11-05
• Results posted: 2021-11-05

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study