CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
filgrastim +13 morebiological
Likely dose
Not stated in record
Key inclusion· 7
  • Histologically confirmed primary intracranial CNS atypical teratoid/rhabdoid tumor (AT/RT)
  • Tumor tissue possesses INI-1 gene mutation
  • Age 18 years or younger
  • Definitive surgical resection of tumor within the past 35 days
Key exclusion· 3
  • Prior chemotherapy
  • Prior radiotherapy
  • Other concurrent investigational agents

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

Search/NCT00084838
NCT00084838Phase 2Completed

A Phase II Study of Intrathecal and Systemic Chemotherapy With Radiation Therapy for Children With Central Nervous System Atypical Teratoid/Rhabdoid Tumor (AT/RT) Tumor

Dana-Farber Cancer Institute·interventional·Posted Jun 11, 2004·Updated Dec 24, 2015

In Brief

A Phase 2 clinical trial evaluating filgrastim, cisplatin, and 12 other interventions for Central Nervous System Tumor, Pediatric. Completed, enrolled 25 participants across 12 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy 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. Giving more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving intrathecal and systemic combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system (CNS) atypical teratoid/rhabdoid tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 11, 2004
Enrollment StartFeb 1, 2003
Primary CompletionFeb 1, 2008
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 22.1 years ago

Interventions

filgrastimbiological

cisplatindrug

cyclophosphamidedrug

cytarabinedrug

dexrazoxane hydrochloridedrug

doxorubicin hydrochloridedrug

etoposidedrug

leucovorin calciumdrug

methotrexatedrug

temozolomidedrug

therapeutic hydrocortisonedrug

vincristine sulfatedrug

radiation therapyradiation

Dactinomycindrug