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NCT Number: NCT00960739

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

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.

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Key information

Conditions

Neuroblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Age range

1 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Oscar Lambret, Lille, France

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About this study

OBJECTIVES:

Primary

  • Determine the antitumor activity of iodobenzylguanidine meta-I131 (^131I-MIBG) and topotecan in young patients with refractory or relapsed metastatic neuroblastoma.

Secondary

  • Determine the hematological and extra-hematological toxicities of this regimen.

OUTLINE: This is a multicenter study.

During the 21 days before treatment begins, autologous peripheral blood stem cells (PBSC) are collected.

Patients receive topotecan hydrochloride IV over 30 minutes daily on days 1-5 and iodobenzylguanidine meta-^131I IV over 2 hours on day 1. Treatment repeats every 21 days for 2 courses. Patients also undergo total-body irradiation.

On day 10 of the second course, autologous PBSC are reinfused.

After completion of study therapy, patients are followed at 6 and 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed neuroblastoma
  • Metastatic disease that is recurrent or refractory to induction therapy
  • Primary or metastatic tumor target with MIBG fixation (tumor/soft tissue) > 2
  • Autologous bone marrow or peripheral blood stem cells must be available
  • WHO performance status (PS) 0-1 OR Lansky PS 70-100%
  • Life expectancy > 2 months
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine clearance normal for age
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior hypersensitivity to topotecan or its excipients
  • No toxicity to other organs ≥ NCI-CTCAE v3.0 grade 2
  • No other debilitating disease
  • No HIV positivity
  • More than 30 days since prior external-beam radiation (6 weeks if cranio-spinal, abdominal, or pulmonary)
  • At least 3 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
  • No other contraindicated biologic therapy that cannot be discontinued for ≥ 4 courses during MIBG therapy

Exclusion criteria

  • Pregnancy or breastfeeding women
  • HIV positive
  • Participation to another phase I,II or III clinical trial
  • Other invalidating pathology
  • Concomitant treatment interfering with MIBG
  • Hypersensibility to Topotecan

Treatment and study plan

Topotecan Hydrochloride

Drug

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)

Other names: Topotecan

autologous hematopoietic stem cell transplantation

Procedure

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

Other names: hematopoietic stem cell transplantation

iobenguane I 131

Radiation

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

total-body irradiation

Radiation

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)

Primary outcomes

  1. Response rate

    Time frame: Up to 12 months

Secondary outcomes

  1. Toxicity

    Time frame: Up to 30 days after study treatment

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • National Cancer Institute, France
  • Novartis Pharmaceuticals

Registry information

Official study title

Phase II Study of the Association of Iodobenzylguanidine Meta-I131 (I131 MIBG) and Topotecan in the Treatment of Refractory or Relapsed Metastatic Neuroblastoma

Acronym: MIITOP

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Aug 18, 2009
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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