CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 70 enrolled
Drug / intervention
Carboplatin +11 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00653068
NCT00653068Phase 3Completed

Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation

Children's Oncology Group·interventional·Posted Apr 4, 2008·Updated Apr 23, 2024

In Brief

A Phase 3 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Autologous Hematopoietic Stem Cell Transplantation, and 10 other interventions for Childhood Atypical Teratoid/Rhabdoid Tumor. Completed, enrolled 70 participants across 94 sites in 3 countries.

Detailed Summary

This phase III trial studies the side effects of combination chemotherapy, 3-dimensional conformal radiation therapy, and an autologous peripheral blood stem cell transplant, and to see how well they work in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy or radiation therapy.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 4, 2008
Enrollment StartFeb 10, 2009
Primary CompletionSep 27, 2016
Study CompletionMar 31, 2024
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 18.2 years ago

Interventions

3-Dimensional Conformal Radiation Therapyradiation

Undergo 3D-CRT

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous PBSC rescue

Carboplatindrug

Given IV

Cisplatindrug

Given IV

Cyclophosphamidedrug

Given IV

Etoposidedrug

Given IV

Filgrastimbiological

Given IV or SC

Laboratory Biomarker Analysisother

Correlative studies

Leucovorin Calciumdrug

Given IV or PO

Methotrexatedrug

Given IV

Thiotepadrug

Given IV

Vincristine Sulfatedrug

Given IV