Comparison of Neurocognitive Outcome in Two Standard Regimen for Treatment of Low-risk Medulloblastoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Nationwide Children's Hospital
Study ID
NCT07291102
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 5 Years
Healthy Volunteers
Not accepted

Interventions

  • Bridging Chemotherapy — DRUG
    One bridging chemotherapy cycle consists of five days of therapy using Carboplatin and etoposide
  • Induction Cycles A1-A3 — DRUG
    Cisplatin, vincristin, etoposide, cyclophosphamide, high-dose methotrexate
  • Induction Cycles A4-5 — DRUG
    Cisplatin, etoposide, cyclophosphamide, high-dose methotrexate
  • Consolidation Cycle A6 — DRUG
    Carboplatin, thiotepa, etoposide
  • HIT-SKK Chemotherapy Cycles B1-3 — DRUG
    Cyclophosphamide, vincristine, high-dose methotrexate, carboplatin, etoposide, i.ventri. methotrexate
  • Modified HIT-SKK Cycle B4-5 — DRUG
    Cyclophosphamide, vincristine, carboplatin, etoposide

Study Details

This is a trial to compare neurocognitive outcomes in the intent-to-treat population 2.5 years after diagnosis between patients with newly diagnosed, non-metastatic, SHH-activated, TP53-wt, non-MYC amplified MF randomized to the interventional arms A ("Head Start 4") or B (HIT-SKK).

Key Dates

Start date
Jul 1, 2026
Status verified
Nov 2025
Primary completion
Oct 31, 2034
Completion
Oct 31, 2038

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: "Head Start" 4
    Arm A consists of 3 to 5 Induction chemotherapy cycles and one high-dose chemotherapy cycle evaluated in the "Head Start" 4 study.
  • Experimental: Arm B: HIT-SKK
    Arm B consists of 3 to 5 cycles of chemotherapy evaluated in the HIT-SKK'92 (Rutkowski et al. 2005) and HIT-2000 (NCT00303810) clinical studies.

Primary Outcome Measure

Neurocognitive Outcomes using WPPSIIV [ Time Frame: 105 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's of AlabamaBirminghamAlabama35233
Girish Dhall, MD
[email protected]
(205) 638-9100
Nationwide Children's HospitalColumbusOhio43205
Maryam Fouladi, MD
[email protected]
6147225758

Find similar trials in Birmingham, AL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Children's of Alabama· Birmingham, ALNationwide Children's Hospital· Columbus, OH

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