NCT00165139

Brief Summary

The main purpose of this study is to determine the short and long term side effects of a very intensive treatment, which includes combinations of chemotherapy drugs followed by radiation therapy and two transplants supported by peripheral blood progenitor cells (stem cells), for children with advanced stage neuroblastoma and sarcomas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 1996

Longer than P75 for phase_2

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

Study Start

First participant enrolled

January 1, 1996

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

November 2, 2009

Status Verified

October 1, 2009

Enrollment Period

4.8 years

First QC Date

September 9, 2005

Last Update Submit

October 30, 2009

Conditions

NeuroblastomaEwings SarcomaNon-rhabdomyosarcoma Soft Tissue Sarcoma

Keywords

Stem cell transplantHigh-risk pediatric tumors

Outcome Measures

Primary Outcomes (1)

  • To determine the toxicity and feasibility of double dose chemo-radiotherapy with blood progenitor cell rescue in this patient population.

    5 years

Interventions

VincristineDRUG

Described under detailed description

CyclophosphamideDRUG

Described under detailed description

AdriamycinDRUG

Described under detailed description

Etoposide (VP-16)DRUG

Described under detailed description

CisplatinDRUG

Described under detailed description

CarboplatinDRUG

Described under detailed description

MelphalanDRUG

Described under detailed description

IfosfamideDRUG

Described under detailed description

G-CSF (granulocyte-colony stimulating factor)DRUG

Described under detailed description

MesnaDRUG

Described under detailed description

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Previously untreated neuroblastoma Stage D \> 365 days
  • Previously untreated neuroblastoma Stage C at age \> 365 days with n-myc amplification
  • Previously untreated metastatic Ewings sarcoma/PNET
  • Previously untreated non-rhabdomyosarcoma soft tissue sarcoma
  • Confirmation of neuroblastoma at time of diagnosis by histologic specimen or with bone marrow specimen showing solid tumor. Confirmation of sarcoma by histologic specimen with evidence of metastatic disease be imaging study
  • Patient 19 years of age or younger
  • ANC \> 1000
  • Platelet count \> 75,000
  • SGOT \< 2.5 x ULN
  • Normal serum creatinine levels for age

You may not qualify if:

  • Previous malignancy requiring nonsurgical treatment or bone marrow transplant.
  • Relapsed disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

NeuroblastomaSarcoma, EwingSarcoma

Interventions

VincristineCyclophosphamideDoxorubicinEtoposideCisplatinCarboplatinMelphalanIfosfamideGranulocyte Colony-Stimulating FactorMesna

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueOsteosarcomaNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCoordination ComplexesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsOxazinesHeterocyclic Compounds, 1-RingColony-Stimulating FactorsGlycoproteinsGlycoconjugatesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesProteinsBiological FactorsAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicSulfhydryl CompoundsSulfur CompoundsSulfonic AcidsSulfur Acids

Study Officials

  • Lisa Diller, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

January 1, 1996

Primary Completion

November 1, 2000

Study Completion

February 1, 2009

Last Updated

November 2, 2009

Record last verified: 2009-10

Locations

US(1)