Standard Regimen Comparison for Medulloblastoma

Not yet recruiting at 1 trial location

Overseen By Kelsey Troyer, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Nationwide Children's Hospital

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Maryam Fouladi, MD

Principal Investigator

Nationwide Children's Hospital

Girish Dhall, MD

Principal Investigator

Children's Hospital of Alabama

Are You a Good Fit for This Trial?

Inclusion Criteria

My family and I can attend follow-up mental health checks.

Ability of parents/legal representatives to understand the patient information and to personally sign and date the informed consent to participate in screening procedures

I and my legal guardian are willing to participate in the study.

Exclusion Criteria

I have a severe developmental delay that prevents me from completing certain assessments.

Patients cannot undergo MRI

My cancer is MYC amplified.

What Are the Treatments Tested in This Trial?

Interventions

• Bridging Chemotherapy
• Consolidation Cycle A6
• HIT-SKK Chemotherapy Cycles B1-3
• Induction Cycles A1-A3
• Induction Cycles A4-5
• Modified HIT-SKK Cycle B4-5

How Is the Trial Designed?

Group I: Arm B: HIT-SKK Experimental Treatment 3 Interventions

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.

Group II: Arm A: "Head Start" 4 Experimental Treatment 4 Interventions

Arm A consists of 3 to 5 Induction chemotherapy cycles and one high-dose chemotherapy cycle evaluated in the "Head Start" 4 study.

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

German Society of Paediatric Oncology and Hematology (GPOH gGmbH)

Collaborator

Children's of Alabama

Collaborator

Trials

10

Recruited

3,000+