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Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma

NCT00808899 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-05-30

Study results available
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Summary

A Phase II study of temsirolimus in combination with standard chemotherapy (irinotecan; cyclophosphamide, doxorubicin and etoposide (CAE); cisplatin and etoposide (HiPE) and topotecan (TPT) followed by and additional six courses of induction chemotherapy and then intensification with autologous hematopoietic stem cell transplantation. The first five courses of induction chemotherapy will also evaluate the feasibility of combining weekly temsirolimus with these standard chemotherapy combinations. This will be followed by 16 months of oral maintenance therapy with eight months of 13-cis-retinoic acid and then eight months of oral topotecan.

Conditions

Interventions

DRUG

Temsirolimus

Temsirolimus

DRUG

Irinotecan

Irinotecan

PROCEDURE

Surgical Resection of Primary Tumor

Surgical Resection of Primary Tumor

DRUG

Cyclophosphamide

Cyclophosphamide

DRUG

Doxorubicin

Doxorubicin

DRUG

Etoposide

Etoposide

DRUG

Cisplatin

Cisplatin

DRUG

Topotecan

Topotecan

PROCEDURE

PBSC

Peripheral Blood Stem Cell Harvest

RADIATION

Radiation Therapy

Radiation Therapy

DRUG

13-cis-retinoic acid

13-cis-retinoic acid

Sponsors & Collaborators

Principal Investigators

  • Wayne L Furman, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00808899 on ClinicalTrials.gov