RecruitingPhase 2NCT05535166

Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma

SJiMB21: Phase 2 Study of Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma


Sponsor

St. Jude Children's Research Hospital

Enrollment

130 participants

Start Date

Dec 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, multinational phase 2 trial that aims to explore the use of molecular and clinical risk-directed therapy in treatment of children 0-4.99 years of age with newly diagnosed medulloblastoma.


Eligibility

Max Age: 59 Months

Plain Language Summary

Simplified for easier understanding

This study is developing a tailored treatment approach for very young children (infants and toddlers) newly diagnosed with medulloblastoma, the most common malignant brain tumor in children. Researchers are using each child's specific tumor characteristics — including molecular markers — to guide how aggressive the treatment should be, aiming to improve survival while reducing long-term side effects. **You may be eligible if:** - Your child is under 3 years old, OR between 3–5 years old with cancer that has not spread - Your child has a new (not previously treated) suspected medulloblastoma - Tumor tissue is available for laboratory testing - Treatment can begin within 36 days of surgery **You may NOT be eligible if:** - Your child is older than 5 years - Tumor tissue is not available or cannot be tested - Treatment cannot start within the required timeframe - Your child has another serious medical condition that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESurgical resection

All participants enrolled will undergo surgical resection prior to treatment. The maximal resection that can be achieved without undue risk to the patient will be attempted, with decisions about feasibility and extent of resection left to the discretion of the neurosurgeon. In instances where an STR is the best extent of resection achieved prior to start of therapy, a "second-look" surgery may be performed between cycles of chemotherapy after discussion with the principal investigator.

PROCEDUREOmmaya/VPS

All participants enrolled on S-1 will undergo

DRUGMethotrexate

Route of administration: Intravenously (IV)

DRUGCisplatin

Route of administration: Intravenously (IV)

DRUGVincristine

Route of administration: Intravenously (IV)

DRUGCyclophosphamide

Route of administration: Intravenously (IV)

DRUGCarboplatin

Route of administration: Intravenously (IV)

DRUGTopotecan

Route of administration: Intravenously (IV)

DRUGEtoposide

Route of administration: Intravenously (IV)

DRUGPegfilgrastim

Route of administration: subcutaneous (SQ)

DRUGFilgrastim

Route of administration: subcutaneous (SQ) or Intravenously (IV)

RADIATIONIrradiation

All participants in stratum N will undergo craniospinal irradiation (CSI) with boost to the primary tumor site once they reach 36 months of age. The dose given is based on the molecular risk group and disease response to chemotherapy as noted in the arm descriptions. The type of radiation used includes conformal radiation therapy (photons) or intensity modulated radiation therapy (IMRT) or proton beam therapy.

OTHEREducational and Media Intervention

Participants watch a 75-minute caregiver education video program and receive access to interactive games on a smartphone or tablet throughout the optional cognitive study.

OTHERSOC, Educational and Media Intervention

Standard-of-care (SOC) treatment during main cognitive study. After the one-year serial cognitive evaluation, participants will be offered participation in the cognitive study group I intervention.

DRUGMethotrexate

Route of administration: Intravenously (IV) \& Intra Ventricular (IVT)


Locations(10)

Lucille Packard Children's Hospital Stanford

Palo Alto, California, United States

Orlando Health Arnold Palmer Hospital for Children

Orlando, Florida, United States

St. Joseph's Children's Hospital

Tampa, Florida, United States

C.S. MOTT Children's Hospital, University of Michigan

Ann Arbor, Michigan, United States

Children's Hospital and Clinics of Minnesota

Minneapolis, Minnesota, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

UT Southwestern Medical Center/Harold C Simmons Comprehensive Cancer Center

Dallas, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

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NCT05535166


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