NCT00618813

Brief Summary

This clinical trial is studying the side effects of combination chemotherapy and to see how well they work in treating patients with newly diagnosed localized Ewing sarcoma family of tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways may kill more tumor cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
4 years until next milestone

Results Posted

Study results publicly available

February 10, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

February 19, 2008

Results QC Date

December 17, 2013

Last Update Submit

September 11, 2014

Conditions

Ewing Sarcoma of BoneLocalized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Outcome Measures

Primary Outcomes (5)

  • Incidence of Death

    Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy

    Length of protocol therapy (up to 37 weeks) plus 30 days

  • Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12

    The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.

    Enrollment to week 12

  • Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22

    The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.

    Week 13 to week 22

  • Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28

    The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.

    Week 23 to week 28

  • Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 29 to Week 37

    The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.

    Week 29 to week 37

Secondary Outcomes (1)

  • Event Free Survival

    From enrollment to event or 10 years from enrollment, whichever occurs first

Study Arms (1)

Treatment (combination chemotherapy)

EXPERIMENTAL

See Detailed Description

Other: radiation therapyOther: therapeutic conventional surgeryDrug: etoposideDrug: ifosfamideDrug: doxorubicin hydrochlorideDrug: cyclophosphamideDrug: vincristine sulfateDrug: topotecan hydrochlorideBiological: filgrastim

Interventions

etoposideDRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213
Treatment (combination chemotherapy)
ifosfamideDRUG

Given IV

Also known as: Cyfos, Holoxan, IFF, IFX, IPP
Treatment (combination chemotherapy)
doxorubicin hydrochlorideDRUG

Given IV

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Treatment (combination chemotherapy)
cyclophosphamideDRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Treatment (combination chemotherapy)
radiation therapyOTHER

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation
Treatment (combination chemotherapy)
therapeutic conventional surgeryOTHER

Undergo surgery

Treatment (combination chemotherapy)
vincristine sulfateDRUG

Given IV

Also known as: leurocristine sulfate, VCR, Vincasar PFS
Treatment (combination chemotherapy)
topotecan hydrochlorideDRUG

Given IV

Also known as: hycamptamine, Hycamtin, SKF S-104864-A, TOPO
Treatment (combination chemotherapy)
filgrastimBIOLOGICAL

Given SC

Also known as: G-CSF, Neupogen
Treatment (combination chemotherapy)

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of extracranial Ewing sarcoma or peripheral primitive neuroectodermal tumor of bone or soft tissue:
  • Newly diagnosed disease
  • Disease confirmed by biopsy only with no attempt at complete or partial resection
  • Unplanned excision allowed provided adequate imaging was obtained prior to surgery and incompletely resected disease is controlled by local therapy
  • No esthesioneuroblastoma
  • Localized disease, including any of the following sites:
  • Chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology, or ipsilateral pleural based secondary tumor nodules;
  • No contralateral pleural effusions or pleural nodules
  • Regional lymph nodes that are clinically suspicious or confirmed by biopsy
  • No distant lymph node metastases
  • Extra-dural tumors arising in the bony skull
  • No tumors arising in the intra-dural soft tissue or the intra-dural region of the spine
  • No evidence of metastatic disease, defined as any of the following:
  • Lesions that are discontinuous from the primary tumor
  • Lesions that are not regional lymph nodes
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91016, United States

Location

MeSH Terms

Conditions

Neuroectodermal Tumors, Primitive, Peripheral

Interventions

RadiotherapyRadiationEtoposideIfosfamideindolepropanol phosphateDoxorubicinCyclophosphamideVincristineTopotecantrioctyl phosphine oxideFilgrastimGranulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical PhenomenaPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDaunorubicinAnthracyclinesNaphthacenesAminoglycosidesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesCamptothecinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Results Reporting Coordinator
Organization
Children's Oncology Group
resultsreportingcoordinator@childrensoncologygroup.org
352-273-0558

Study Officials

  • Leo Mascarenhas, MD MS

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 20, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2010

Last Updated

September 25, 2014

Results First Posted

February 10, 2014

Record last verified: 2014-09

Locations

US(1)