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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00960739
First received: August 16, 2009
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Neuroblastoma
Drug: topotecan hydrochloride
Procedure: autologous hematopoietic stem cell transplantation
Radiation: iobenguane I 131
Radiation: total-body irradiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of the Association of Iodobenzylguanidine Meta-I131 (I131 MIBG) and Topotecan in the Treatment of Refractory or Relapsed Metastatic Neuroblastoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: January 2009
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00960739

Locations
France
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Anne-Sophie Defachelles    33-32-029-5959      
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Anne-Sophie Defachelles Centre Oscar Lambret
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00960739     History of Changes
Other Study ID Numbers: CDR0000633586, COL-MIITOP, COL-2006-07, INCA-RECF0633, EUDRACT-2006-004862-15
Study First Received: August 16, 2009
Last Updated: September 17, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
disseminated neuroblastoma
localized unresectable neuroblastoma
recurrent neuroblastoma
stage 4S neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
3-Iodobenzylguanidine
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014