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Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma

NCT00960739 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-08-08

No results posted yet for this study

Summary

RATIONALE: Radioactive drugs, such as iodobenzylguanidine meta-I131, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A stem cell transplant may be able to replace the cells that were destroyed by iodobenzylguanidine meta-i131 and topotecan hydrochloride.

PURPOSE: This phase II trial is studying the side effects of iodobenzylguanidine meta-I131 given together with topotecan hydrochloride and to see how well it works in treating young patients with refractory or relapsed metastatic neuroblastoma.

Conditions

Interventions

DRUG

Topotecan hydrochloride

The topotecan hydrochloride is administered intravenously over five days to dose of 0.7 mg/ m²/day from day 1 to day 5 (first cycle), then from day 21 to day 25 (second cycle)

PROCEDURE

Autologous hematopoietic stem cell transplantation

Hematopoietic stem cells are reinjected 10 days after the second injection of 131-iodine MIBG

RADIATION

iobenguane I 131

444 MBq / kg of 131-iodine MIBG is administered on day 1 with activity

RADIATION

total-body irradiation

the dose of total-body irradiation of 4 Gy is reached during the first cycle, the second cycle is canceled (131-iodine MIBG and Topotecan)

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Anne Sophie Defachelles, MD · Centre Oscar Lambret

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2016-03-31
Completion
2016-07-31

Countries

  • France

Study Locations

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Entities

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 NCT00960739 on ClinicalTrials.gov