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Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma

NCT02306161 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2026-04-13

Study results available
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Summary

This randomized phase III trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Treatment with drugs that block the IGF-1R pathway, such as ganitumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether adding ganitumab to combination chemotherapy is more effective in treating patients with newly diagnosed metastatic Ewing sarcoma.

Conditions

  • Metastatic Ewing Sarcoma
  • Metastatic Malignant Neoplasm in the Bone
  • Metastatic Malignant Neoplasm in the Bone Marrow
  • Metastatic Malignant Neoplasm in the Lung
  • Metastatic Peripheral Primitive Neuroectodermal Tumor of Bone
  • Peripheral Primitive Neuroectodermal Tumor of Soft Tissues

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

DRUG

Etoposide Phosphate

Given IV

RADIATION

External Beam Radiation Therapy

Undergo EBRT

BIOLOGICAL

Ganitumab

Given IV

DRUG

Ifosfamide

Given IV

RADIATION

Stereotactic Radiosurgery

Undergo SBRT

PROCEDURE

Therapeutic Surgical Procedure

Undergo surgery

DRUG

Vincristine

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Steven G DuBois · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-12
Primary Completion
2021-03-31
Completion
2026-09-17

Countries

  • United States
  • Canada
  • Puerto Rico

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 NCT02306161 on ClinicalTrials.gov