NCT00004188|CompletedPhase 3DMC

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma

A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma

Children's Oncology Group ClinicalTrials.gov

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7 other identifiers

A3973COG-A3973CCG-A3973POG-A3973CCG-39703FHCRC-1631.00CDR0000067429

Study Type

interventional

Target

495

Locations

2 countries

Sites

Timeline

RegisteredJan 2003

StartedFeb 2001

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation with treated peripheral stem cells following combination chemotherapy to see how well it works compared to peripheral stem cell transplantation with untreated peripheral stem cells following combination chemotherapy in treating patients with neuroblastoma.

Trial Health

On Track

Trial Health Score

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

Enrollment

495

participants targeted

Target at P50-P75 for phase_3

Geographic Reach

2 countries

96 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

First Submitted

Initial submission to the registry

January 21, 2000

Completed

1 year until next milestone

Study Start

First participant enrolled

February 1, 2001

Completed

2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed

Last Updated

May 17, 2013

Status Verified

May 1, 2013

Enrollment Period

6.7 years

First QC Date

January 21, 2000

Last Update Submit

May 16, 2013

Conditions

Neuroblastoma

Keywords

localized resectable neuroblastomaregional neuroblastomadisseminated neuroblastomastage 4S neuroblastomalocalized unresectable neuroblastoma

Outcome Measures

Primary Outcomes (2)

Event-free survival rate
Time from study registration until the time of the first occurrence of either relapse, progression, secondary malignancy, or death, or until the time of last contact with the patient if none of these events occurs, assessed up to 6 years
Rate of occurrence of toxic (non disease-related) deaths where a toxic death will be "counted" if it occurs prior to the initiation of the immunotherapy
Up to day 42

Secondary Outcomes (3)

Time to engraftment
Up to 6 years
CD34 content
Up to 6 years
Tumor content as measured by reverse transcriptase polymerase chain reaction
Up to 6 years

Study Arms (2)

Arm I (unpurged PBSC collection)

EXPERIMENTAL

Induction-3 wks (cyclophosphamide day 0\&1, doxorubicin hydrochloride \& vincristine sulfate day 0-2 \& filgrastim(G-CSF) day 3 crs 1,2,4 \& 6.) Crs 3 \& 5 (etoposide day 0-2, cisplatin day 0-3, G-CSF day 4). Pts undergo unpurged PBSC collection until the target cell count is reached. Surgical resection of the tumor after crs 5 of induct. CR, VGPR, PR after induct receive consolidation (melphalan day -7 to -5, carboplatin \& etoposide day -7 to -4. purged peripheral blood stem cell transplantation infusion day 0, G-CSF 4 hrs post transplant. Day 66, isotretinoin 2x day/14 days. Isotretinoin every 4 wks 6 crs. After consol (28 days from stem cell infusion), radiation therapy 1x day/7 days. Not undergoing autologous bone marrow transplantation receive maintenance(cyclophosphamide 30 mins, topotecan hydrochloride days 0-4, G-CSF day 5). Maint every 3 wks/3 crs. Radiation therapy and Isotretinoin 2x day/14 days then every 4 wks for 6 crs.

Biological: filgrastimDrug: carboplatinDrug: cisplatinDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: etoposideDrug: isotretinoinDrug: melphalanDrug: topotecan hydrochlorideDrug: vincristine sulfateProcedure: autologous bone marrow transplantationProcedure: bone marrow ablation with stem cell supportProcedure: conventional surgeryProcedure: peripheral blood stem cell transplantationRadiation: radiation therapy

Arm II (unpurged PBSC collection)

EXPERIMENTAL

Induction-3 wks (cyclophosphamide day 0\&1, doxorubicin hydrochloride \& vincristine sulfate day 0-2 \& filgrastim(G-CSF) day 3 crs 1,2,4 \& 6.) Crs 3 \& 5 (etoposide day 0-2, cisplatin day 0-3, G-CSF day 4). Immunocytology + PBSC undergo purged autologous bone marrow collection or repeat purged or unpurged PBSC collection. Surgical resection of the tumor after crs 5 of induct. CR, VGPR, PR after induct receive consolidation (melphalan day -7 to -5, carboplatin \& etoposide day -7 to -4. Unpurged peripheral blood stem cell transplantation infusion day 0, G-CSF 4 hrs post transplant. Day 66, isotretinoin 2x day/14 days. Isotretinoin every 4 wks 6 crs. After consol (28 days from stem cell infusion), radiation therapy 1x day/7 days. Not undergoing autologous bone marrow transplantation receive maintenance(cyclophosphamide 30 mins, topotecan hydrochloride days 0-4, G-CSF day 5). Maint every 3 wks/3 crs. Radiation therapy and Isotretinoin 2x day/14 days then every 4 wks for 6 crs.

Drug: carboplatinDrug: cisplatinDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: etoposideDrug: isotretinoinDrug: melphalanDrug: topotecan hydrochlorideDrug: vincristine sulfateProcedure: autologous bone marrow transplantationProcedure: bone marrow ablation with stem cell supportProcedure: conventional surgeryProcedure: peripheral blood stem cell transplantationRadiation: radiation therapy

Interventions

filgrastimBIOLOGICAL

Given IV

Also known as: GRANULOCYTE COLONY-STIMULATING FACTOR, r-metHuG-CSF, G-CSF, Neupogen, NSC 614629

Arm I (unpurged PBSC collection)

carboplatinDRUG

Given IV

Also known as: Paraplatin, NSC #241240