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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT01946529
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Desmoplastic Small Round Cell Tumor
  • Ewing Sarcoma of Bone or Soft Tissue
  • Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Eligibility Criteria

Sex
ALL
Age
N/A - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • vincristine — DRUG
    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).
  • doxorubicin — DRUG
    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.
  • cyclophosphamide — DRUG
    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.
  • ifosfamide — DRUG
    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.
  • etoposide — DRUG
    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.
  • temozolomide — DRUG
    Dosage and route of administration: Temozolomide 100 mg/m\^2 PO once daily, days 1-5.
  • temsirolimus — DRUG
    Dosage and route of administration: Temsirolimus 35 mg/m\^2 IV once day 1 and day 8.
  • bevacizumab — DRUG
    Dosage and route of administration: Bevacizumab 15 mg/kg IV on day 1 every 3 weeks.
  • sorafenib — DRUG
    Dosage and route of administration: 90 mg/m\^2/dose PO BID
  • surgery — PROCEDURE
    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.

Study Details

This protocol will study treatment for Ewing sarcoma family of tumors (ESFT) and desmoplastic small round cell tumor (DSRCT). Participants with ESFT will be divided into two treatment groups, A or B, based on tumor characteristics. Group A (standard risk) participants have tumor that is not in the pelvis, has not spread to other parts of the body, and are less than 14 years of age. Because previous clinical trials have shown that standard treatment is very effective for children whose tumors have these characteristics, these participants will receive standard treatment. Group B (high risk) participants are 14 years of age or older or have tumor in the pelvis, or the tumor has spread to other parts of the body. Participants with DSRCT in the abdomen and/or pelvis or with tumor that cannot be removed by surgery alone or has spread to other parts of the body will be included in Group B. Participants in this group are considered high risk because there is a greater chance of tumor recurring following standard treatments currently in use. All participants will be followed and evaluated for 10 years following completion of therapy.

Key Dates

First listed
Sep 19, 2013
Start date
Dec 27, 2013
Status verified
Feb 2026
Primary completion
Aug 31, 2015
Completion
Jul 31, 2026

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A (Standard Risk)
    Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m\^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
  • Active Comparator: Group B (High Risk)
    Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide, etoposide, irinotecan, temozolomide, temsirolimus, bevacizumab, and sorafenib. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone or surgery followed by radiation.

Primary Outcome Measure

Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants [ Time Frame: at 6 weeks after start of therapy (after 2 initial courses) ]

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105-

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