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A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma
NCT01878617 · View on ClinicalTrials.gov ↗
Study Summary
Historically, medulloblastoma treatment has been determined by the amount of leftover disease present after surgery, also known as clinical risk (standard vs. high risk). Recent studies have shown that medulloblastoma is made up of distinct molecular subgroups which respond differently to treatment. This suggests that clinical risk alone is not adequate to identify actual risk of recurrence. In order to address this, we will stratify medulloblastoma treatment in this phase II clinical trial based on both clinical risk (low, standard, intermediate, or high risk) and molecular subtype (WNT, SHH, or Non-WNT Non-SHH). This stratified clinical and molecular treatment approach will be used to evaluate the following: * To find out if participants with low-risk WNT tumors can be treated with a lower dose of radiation to the brain and spine, and a lower dose of the chemotherapy drug cyclophosphamide while still achieving the same survival rate as past St. Jude studies with fewer side effects. * To find out if adding targeted chemotherapy after standard chemotherapy will benefit participants with SHH positive tumors. * To find out if adding new chemotherapy agents to the standard chemotherapy will improve the outcome for intermediate and high risk Non-WNT Non-SHH tumors. * To define the cure rate for standard risk Non-WNT Non-SHH tumors treated with reduced dose cyclophosphamide and compare this to participants from the past St. Jude study. All participants on this study will have surgery to remove as much of the primary tumor as safely possible, radiation therapy, and chemotherapy. The amount of radiation therapy and type of chemotherapy received will be determined by the participant's treatment stratum. Treatment stratum assignment will be based on the tumor's molecular subgroup assignment and clinical risk. The participant will be assigned to one of three medulloblastoma subgroups determined by analysis of the tumor tissue for tumor biomarkers: * WNT (Strata W): positi
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Cisplatin
- DRUG Vincristine
- DRUG Vismodegib
- RADIATION Craniospinal Irradiation with boost to the primary tumor site
Study Locations (20)
Texas
- University of Texas Southwestern Medical Center — Dallas
- Cook Children's Medical Center — Fort Worth
- Texas Children's Cancer Center — Houston
California
- Lucille Packard Children's Hospital at Stanford University Medical Center — Palo Alto
- Rady Children's Hospital — San Diego
Florida
- University of Florida — Gainesville
- Arnold Palmer Hospital for Children — Orlando
New South Wales
- Sydney Children's Hospital — Randwick
- Children's Hospital at Westmead — Westmead
Connecticut
- Yale University — New Haven
District of Columbia
- Children's National Medical Center — Washington D.C.
Minnesota
- Children's Hospital and Clinics of Minnesota — Minneapolis
North Carolina
- Duke Children's Hospital and Health Center — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2013-06-23 |
| Est. Completion | 2031-10-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01878617
The ClinicalTrials.gov registry entry for NCT01878617 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 660 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 441 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Medulloblastoma appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01878617 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Texas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01878617 about?
NCT01878617 is a clinical study titled "A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma". Historically, medulloblastoma treatment has been determined by the amount of leftover disease present after surgery, also known as clinical risk (standard vs. high risk). Recent studies have shown that medulloblastoma is made up of distinct molecular subgroups which respond differently to treatment....
What is the current status of trial NCT01878617?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 660 participants. The study started on 2013-06-23. Estimated completion is 2031-10-13.
What conditions does trial NCT01878617 study?
This clinical trial studies the following conditions: Medulloblastoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01878617?
The interventions under investigation include: Cyclophosphamide (DRUG), Cisplatin (DRUG), Vincristine (DRUG), Vismodegib (DRUG), Craniospinal Irradiation with boost to the primary tumor site (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01878617?
This trial is sponsored by St. Jude Children's Research Hospital, which has 441 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01878617 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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