CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 416 enrolled
Drug / intervention
filgrastim +5 morebiological
Likely dose
Cisplatin IV, cyclophosphamide IV, vincristine IV, filgrastim subcutaneously, autologous hematopoietic stem cell transplantation, craniospinal radiotherapy once daily 5 days a week for 6 weeks (specific doses not stated in source)AI-extracted
Key inclusion· 6
  • Histologically confirmed medulloblastoma, supratentorial PNET (including variants), or ATRT
  • Age 3 to 21 years at diagnosis
  • Definitive CNS tumor surgery performed within 31 days
  • Average-risk disease: localized with no invasion beyond fossa/compartment; or T4 with gross total resection, residual <1.5 cm², and no CNS/extraneural metastasis
Key exclusion· 7
  • Prior chemotherapy
  • Prior radiotherapy
  • Pregnant or nursing
  • Hemoglobin ≤8 g/dL

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00085202
NCT00085202Phase 3Completed

Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor

St. Jude Children's Research Hospital·interventional·Posted Jun 11, 2004·Updated Feb 8, 2024

In Brief

A Phase 3 clinical trial evaluating filgrastim, cisplatin, and 4 other interventions for Brain and Central Nervous System Tumors. Completed, enrolled 416 participants across 9 sites in 3 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 11, 2004
Enrollment StartAug 1, 2003
Primary CompletionDec 1, 2016
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 13.3 yearsPosted 22.1 years ago

Interventions

filgrastimbiological

Given subcutaneously

cisplatindrug

Given IV

cyclophosphamidedrug

Given IV

vincristinedrug

Given IV

autologous hematopoietic stem cell transplantationprocedure

Patients undergo autologous stem cell transplantation

radiation therapyradiation

Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks.