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Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
NCT00085202 · View on ClinicalTrials.gov ↗
Study Summary
Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. It is not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell transplant is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. This phase III trial is studying two different regimens of radiation therapy when given together with chemotherapy and autologous stem cell transplant to see how well they work in treating patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. PRIMARY OBJECTIVE: * To assess the relationship between ERBB2 protein expression in tumors and progression-free survival probability for patients with medulloblastoma. * To estimate the frequency of mutations associated with SHH and WNT tumors (as defined by gene expression profiling) via targeted sequencing performed in an independent cohort of WNT and SHH tumors (also defined by gene expression profiling).
Conditions Studied
Interventions
- DRUG cisplatin
- DRUG cyclophosphamide
- PROCEDURE autologous hematopoietic stem cell transplantation
- DRUG vincristine
- BIOLOGICAL filgrastim
Study Locations (9)
New South Wales
- Sydney Children's Hospital — Randwick
- Children's Hospital at Westmead — Westmead
North Carolina
- Duke Comprehensive Cancer Center — Durham
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Tennessee
- St. Jude Children's Research Hospital — Memphis
Texas
- Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital — Houston
Queensland
- Lady Cilento Children's Hospital, Brisbane — Brisbane
Victoria
- Royal Children's Hospital — Parkville
Ontario
- Hospital for Sick Children — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2003-08 |
| Est. Completion | 2023-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00085202
The ClinicalTrials.gov registry entry for NCT00085202 describes a study currently listed as completed. It is categorized as Phase 3, 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 416 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 Brain and Central Nervous System Tumors appearing as the primary indexed condition, and to 5 interventions — of which cisplatin 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: NCT00085202 reports 9 study locations spanning 8 distinct geographic areas — top geographies include New South Wales, North Carolina, Pennsylvania. 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 NCT00085202 about?
NCT00085202 is a clinical study titled "Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor". Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor c...
What is the current status of trial NCT00085202?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 416 participants. The study started on 2003-08. Estimated completion is 2023-12-31.
What conditions does trial NCT00085202 study?
This clinical trial studies the following conditions: Brain and Central Nervous System Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00085202?
The interventions under investigation include: cisplatin (DRUG), cyclophosphamide (DRUG), autologous hematopoietic stem cell transplantation (PROCEDURE), vincristine (DRUG), filgrastim (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00085202?
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 NCT00085202 being conducted?
This trial has 9 study locations across North Carolina, Pennsylvania, Tennessee, Texas, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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