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High-Dose Iodine I 131 Metaiodobenzylguanidine, Topotecan, and Peripheral Stem Cell Transplant in Treating Young Patients With Relapsed Stage 4 Neuroblastoma or Primary Resistant High-Risk Neuroblastoma

NCT00389766 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-07-10

No results posted yet for this study

Summary

RATIONALE: Radioisotope therapy, such as iodine I 131 metaiodobenzylguanidine (MIBG), releases radiation that kills tumor cells. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Topotecan may also make tumor cells more sensitive to iodine I 131 MIBG. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by iodine I 131 MIBG and topotecan. This may allow more iodine I 131 MIBG and topotecan to be given so that more tumor cells are killed.

PURPOSE: This phase II trial is studying how well giving high-dose iodine I 131 MIBG together with topotecan and peripheral stem cell transplant works in treating young patients with relapsed stage 4 neuroblastoma or primary resistant high-risk neuroblastoma.

Conditions

Interventions

DRUG

iodine I 131 metaiodobenzylguanidine

DRUG

topotecan hydrochloride

PROCEDURE

chemotherapy

PROCEDURE

peripheral blood stem cell transplantation

PROCEDURE

radioisotope therapy

PROCEDURE

radionuclide imaging

PROCEDURE

radiosensitization

PROCEDURE

total-body irradiation

Sponsors & Collaborators

  • Children's Cancer and Leukaemia Group

    lead OTHER

Principal Investigators

  • Mark N. Gaze, MD · University College London Hospitals

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-07-31

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Entities

Diseases

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 NCT00389766 on ClinicalTrials.gov