NCT00186849

Brief Summary

This is a Phase II pilot study of chemotherapy and surgery for children with advanced stage high-risk neuroblastoma utilizing topotecan during an upfront window and other active agents during induction and intensification phases. The primary purpose is to estimate the response rate to an upfront window of two cycles of intravenous topotecan. We hypothesize that the topotecan window will be an effective therapy in terms of the response rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 1997

Typical duration 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

October 1, 1997

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

May 20, 2009

Status Verified

May 1, 2009

Enrollment Period

3.5 years

First QC Date

September 12, 2005

Last Update Submit

May 19, 2009

Conditions

Neuroblastoma

Keywords

Neuroblastoma

Outcome Measures

Primary Outcomes (1)

  • Response rate

    5 years

Secondary Outcomes (1)

  • Feasibility/toxicity of an intensification phase of high-dose chemotherapy with topotecan and cyclophosphamide followed by autologous peripheral blood stem cell transplant

    5 years

Study Arms (1)

1

OTHER
Drug: Topotecan, Cyclophosphamide, Cisplatin, Doxorubicin, Etoposide, Ifosfamide, CarboplatinProcedure: Peripheral Blood Stem Cell Transplant

Interventions

Topotecan, Cyclophosphamide, Cisplatin, Doxorubicin, Etoposide, Ifosfamide, CarboplatinDRUG

See Detailed Description section for details of treatment interventions.

1
Peripheral Blood Stem Cell TransplantPROCEDURE

See Detailed Description section for details of treatment interventions.

1

Eligibility Criteria

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

You may qualify if:

  • Advanced stage,high-risk neuroblastoma
  • Histologic proof of neuroblastoma
  • Adequate renal function
  • ECOG performance status 0-2

You may not qualify if:

  • Previous therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

  • Santana VM, Furman WL, Billups CA, Hoffer F, Davidoff AM, Houghton PJ, Stewart CF. Improved response in high-risk neuroblastoma with protracted topotecan administration using a pharmacokinetically guided dosing approach. J Clin Oncol. 2005 Jun 20;23(18):4039-47. doi: 10.1200/JCO.2005.02.097.

    PMID: 15961757BACKGROUND

Related Links

MeSH Terms

Conditions

Neuroblastoma

Interventions

TopotecanCyclophosphamideCisplatinDoxorubicinEtoposideIfosfamideCarboplatinPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesOxazinesHeterocyclic Compounds, 1-RingCoordination ComplexesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Wayne L. Furman, MD

    St. Jude Children's Research Hospital

    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 12, 2005

First Posted

September 16, 2005

Study Start

October 1, 1997

Primary Completion

April 1, 2001

Study Completion

April 1, 2001

Last Updated

May 20, 2009

Record last verified: 2009-05

Locations

US(1)