Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

December 27, 2013

Primary Completion Date

August 31, 2015

Study Completion Date

July 31, 2026

Conditions
Desmoplastic Small Round Cell TumorEwing Sarcoma of Bone or Soft TissueLocalized Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorMetastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Interventions
DRUG

vincristine

Dosage and route of administration: Infants \< 12 months of age: 0.05 mg/kg IV day 1; participants ≥ 12 months of age: 1.5 mg/m\^2 IV day 1 (max. dose 2 mg).

DRUG

doxorubicin

Dosage and route of administration: Infants \< 1 year 2.5 mg/kg continuous infusion (CI) over 48 hours, days 1-2; participants \> 1 year of age 75 mg/m\^2 CI over 48 hours, days 1-2.

DRUG

cyclophosphamide

Dosage and route of administration: The dose and route are different in neo-adjuvant/adjuvant chemotherapy and maintenance therapy. Please see the Detailed Description for further information.

DRUG

ifosfamide

Dosage and route of administration: Infants \< 1 year of age 60 mg/kg/day IV over 60 minutes days 1-5; participants \> 12 months of age 1800 mg/m\^2 IV over 60 minutes x 5 days, days 1-5.

DRUG

etoposide

Dosage and route of administration: Infants \< 1 year of age 3.3 mg/kg/day IV over 60 minutes days 1-5; children \> 1 year 100 mg/m\^2 daily IV over 60 minutes days 1-5.

DRUG

temozolomide

Dosage and route of administration: Temozolomide 100 mg/m\^2 PO once daily, days 1-5.

DRUG

temsirolimus

Dosage and route of administration: Temsirolimus 35 mg/m\^2 IV once day 1 and day 8.

DRUG

bevacizumab

Dosage and route of administration: Bevacizumab 15 mg/kg IV on day 1 every 3 weeks.

DRUG

sorafenib

Dosage and route of administration: 90 mg/m\^2/dose PO BID

PROCEDURE

surgery

If participant meets the criteria, they will have surgical resection of their tumor.

RADIATION

radiation

If the participant meets the criteria, participants will receive radiation therapy. Chemotherapy will continue during radiation.

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
collaborator

University of Tennessee

OTHER

collaborator

University of Florida

OTHER

collaborator

Nemours Children's Clinic

OTHER

lead

St. Jude Children's Research Hospital

OTHER