NCT02306161|Active Not RecruitingPhase 3Results

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

Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008) to Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma

National Cancer Institute (NCI)ClinicalTrials.gov

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5 other identifiers

NCI-2014-02380AEWS1221s15-00442U10CA098543U10CA180886

Study Type

interventional

Target

312

Locations

3 countries

Sites

315

Timeline

RegisteredDec 2014

StartedDec 2014

CompletionSep 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

312

participants targeted

Target at P50-P75 for phase_3

Timeline

3mo left

Started Dec 2014

Longer than P75 for phase_3

Geographic Reach

3 countries

315 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11.8 years study duration

Study Progress98%

Dec 2014Sep 2026

First Submitted

Initial submission to the registry

December 1, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed

9 days until next milestone

Study Start

First participant enrolled

December 12, 2014

Completed

6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

July 1, 2022

Completed

4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2026

Expected

Last Updated

June 3, 2026

Status Verified

March 1, 2026

Enrollment Period

6.3 years

First QC Date

December 1, 2014

Results QC Date

April 27, 2022

Last Update Submit

June 2, 2026

Conditions

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

Outcome Measures

Primary Outcomes (1)

Event-free Survival
Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.
5 years after enrollment

Secondary Outcomes (2)

Overall Survival
5 years after enrollment
Frequency of Toxicity-events
Up to 202 days

Other Outcomes (11)

Serum IGF Pathway Component and Tissue Protein, Deoxyribonucleic Acid (DNA), and Ribonucleic Acid Markers
Up to 10 years
Tumor Cell Surface IGF-1R Expression
Up to 307 days
Germline Polymorphisms in EGFR
Up to 10 years
+8 more other outcomes

Study Arms (2)

Regimen A (VDC/IE)

EXPERIMENTAL

See Design Details.

Drug: CyclophosphamideDrug: DoxorubicinDrug: Doxorubicin HydrochlorideDrug: EtoposideDrug: Etoposide PhosphateRadiation: External Beam Radiation TherapyDrug: IfosfamideRadiation: Stereotactic RadiosurgeryProcedure: Therapeutic Surgical ProcedureDrug: VincristineDrug: Vincristine Sulfate

Regimen B (VDC/IE + ganitumab)

EXPERIMENTAL

INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles.

Drug: CyclophosphamideDrug: DoxorubicinDrug: Doxorubicin HydrochlorideDrug: EtoposideDrug: Etoposide PhosphateRadiation: External Beam Radiation TherapyBiological: GanitumabDrug: IfosfamideRadiation: Stereotactic RadiosurgeryProcedure: Therapeutic Surgical ProcedureDrug: VincristineDrug: Vincristine Sulfate

Interventions

GanitumabBIOLOGICAL

Given IV

Also known as: AMG 479, AMG-479, AMG479, Anti-IGF-1R Human Monoclonal Antibody AMG-479

Regimen B (VDC/IE + ganitumab)

IfosfamideDRUG

Given IV

Also known as: Asta Z 4942, Asta Z-4942, Cyfos, Holoxan, Holoxane, Ifex, IFO, IFO-Cell, Ifolem, Ifomida, Ifomide, Ifosfamidum, Ifoxan, IFX, Iphosphamid, Iphosphamide, Iso-Endoxan, Isoendoxan, Isophosphamide, Mitoxana, MJF 9325, MJF-9325, Naxamide, Seromida, Tronoxal, Z 4942, Z-4942