MedTrace Logo

Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System

NCT00653068 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-04-23

Study results available
· View outcomes & findings →

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.

Conditions

  • Childhood Atypical Teratoid/Rhabdoid Tumor

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3D-CRT

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous PBSC rescue

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given IV or SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leucovorin Calcium

Given IV or PO

DRUG

Methotrexate

Given IV

DRUG

Thiotepa

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Alyssa T Reddy · Children's Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-10
Primary Completion
2016-09-27
Completion
2024-03-31

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00653068 on ClinicalTrials.gov