NCT00002740|CompletedPhase 1DMC

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation Followed by Surgery and/or Radiation Therapy in Treating Young Patients With Advanced Neuroblastoma

Phase I Pilot Study of Multiple Cycles of High Dose Chemotherapy With Peripheral Blood Stem Cell Infusions In Advanced Stage Neuroblastoma

Children's Oncology Group ClinicalTrials.gov

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3 other identifiers

3951CCG-3951CDR0000064656

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJun 2004

StartedMay 1996

CompletionSep 2005

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation followed by surgery and/or radiation therapy in treating young patients who have newly diagnosed advanced neuroblastoma.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started May 1996

Longer than P75 for phase_1

Geographic Reach

1 country

7 active sites

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

9.3 years study duration

Study Start

First participant enrolled

May 1, 1996

Completed

3.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed

4 months until next milestone

First Posted

Study publicly available on registry

June 16, 2004

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed

Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

7.8 years

First QC Date

November 1, 1999

Last Update Submit

July 23, 2014

Conditions

Neuroblastoma

Keywords

disseminated neuroblastoma

Outcome Measures

Primary Outcomes (1)

Event Free Survival
Determine the maximum tolerated dose of a combination of cyclophosphamide, carboplatin, and etoposide for 3 consecutive courses following 2 cycles of a fixed dose of high dose cyclophosphamide, doxorubicin, and vincristine given on a 21 day schedule using G-CSF in combination with peripheral blood stem cells.

Study Arms (1)

Treatment - Carboplatin Chemotherapy

EXPERIMENTAL

See detailed description.

Biological: filgrastimDrug: carboplatinDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: etoposideDrug: mesnaDrug: vincristine sulfateProcedure: conventional surgeryProcedure: peripheral blood stem cell transplantationRadiation: low-LET cobalt-60 gamma ray therapyRadiation: low-LET photon therapy