HeadStart4: Study for Children Under 10 with Newly Diagnosed Medulloblastoma and Other Brain or Spinal Cord Tumors
Sponsor: Parth Patel
ClinicalTrials ID:NCT02875314
This clinical trial is exploring whether a more intensive treatment plan can improve survival rates for young children with high-risk medulloblastoma and other central nervous system (CNS) tumors. The study compares two treatment approaches to see which is more effective and manageable for patients.
Patient Parameters
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Program Overview
This study is testing two different treatment plans for children under 10 years old who have been newly diagnosed with high-risk medulloblastoma or other CNS embryonal tumors. The goal is to find out if a more intensive treatment plan, involving multiple cycles of chemotherapy, can improve survival rates without causing too many side effects. The study will also look at whether the extra effort and hospital time required for the intensive treatment is worth the potential benefits.
Description
The HeadStart4 study is designed to find the best treatment approach for young children with certain types of brain and spinal cord tumors. Children will receive an initial treatment called Induction, which involves several cycles of chemotherapy. Depending on how well the cancer responds, children will then be randomly assigned to receive either one cycle or three cycles of a more intensive chemotherapy treatment called Consolidation.
The study aims to see if the more intensive treatment can improve survival rates without adding too many side effects. Children with different types of medulloblastoma and CNS embryonal tumors will be included, and the study will track their progress to determine which treatment plan offers the best outcomes.
Eligibility Criteria
Inclusion Criteria
- Children under 10 years old at the time of diagnosis.
- Must not have received any prior chemotherapy or radiation (except for corticosteroids).
- Must have a confirmed diagnosis of medulloblastoma or other specific CNS embryonal tumors.
- Must start chemotherapy within 28 days of surgery and within 21 days of recent MRI scans and spinal fluid tests.
- Must have adequate liver, kidney, and bone marrow function as shown by specific medical tests.
Exclusion Criteria
- Children older than 10 years at diagnosis.
- Certain types of brain tumors, such as atypical teratoid/rhabdoid tumors, ependymomas, and others, are not eligible.
- Children with unbiopsied diffuse intrinsic pontine tumors are not eligible.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's of Alabama | 35233 | Birmingham | Alabama |
| Phoenix Children's Hospital | 85016 | Phoenix | Arizona |
| Arkansas Children's Hospital | 72202 | Little Rock | Arkansas |
| Loma Linda University Medical Center | 92350 | Loma Linda | California |
| Memorial Care Health Services | 90806 | Long Beach | California |
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Mattel Children's Hospital (UCLA) | 90095 | Los Angeles | California |
| UCSF Oakland Benioff | 94609 | Oakland | California |
| Children's Hospital Orange County | 91868 | Orange | California |
| Children's Hospital Colorado | 80045 | Aurora | Colorado |
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