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Whole-Body Radiation Therapy, Systemic Chemotherapy, and High-Dose Chemotherapy Followed By Stem Cell Rescue in Treating Patients With Poor-Risk Ewing Sarcoma

NCT01795430 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-01-09

No results posted yet for this study

Summary

This pilot clinical trial studies whole-body radiation therapy, systemic chemotherapy, and high-dose chemotherapy followed by stem cell rescue in treating patients with poor-risk Ewing sarcoma. Giving chemotherapy and radiation therapy before a peripheral blood stem cell or bone marrow transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is given to prepare the bone marrow for stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy

Conditions

  • Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)
  • Ewing Sarcoma of Bone
  • Extraosseous Ewing Sarcoma
  • Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor

Interventions

DRUG

etoposide

Given IV

DRUG

ifosfamide

Given IV

RADIATION

intensity-modulated radiation therapy

Undergo WB-MRI-guided IMRT

DRUG

topotecan hydrochloride

Given IV

DRUG

busulfan

Given IV

DRUG

melphalan

Given IV

PROCEDURE

autologous hematopoietic stem cell transplantation

Undergo autologous peripheral blood stem cell or bone marrow transplant

PROCEDURE

peripheral blood stem cell transplantation

Undergo autologous peripheral blood stem cell transplant

PROCEDURE

autologous bone marrow transplantation

Undergo autologous bone marrow transplant

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Anna Pawlowska · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2018-03-31

Countries

  • United States

Study Locations

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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 NCT01795430 on ClinicalTrials.gov