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

This study has been withdrawn prior to enrollment.
(Withdrawn because protocol has been discontinued. It was never opened.)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00389766
First received: October 18, 2006
Last updated: July 9, 2013
Last verified: June 2007

October 18, 2006
July 9, 2013
July 2008
July 2008   (final data collection date for primary outcome measure)
  • Proportion of patients who respond to treatment (partial response and complete response at metastatic sites) as measured by metaiodobenzylguanidine scintigraphy and positron emission tomography and CT imaging [ Designated as safety issue: No ]
  • Proportion of patients who are able to progress to potentially curative treatment with surgery and further systemic treatment [ Designated as safety issue: No ]
  • Correlation of tumor dosimetry with response [ Designated as safety issue: No ]
  • Time to tumor progression [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00389766 on ClinicalTrials.gov Archive Site
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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
International Phase II Studies of I-mIBG in Combination With Topotecan and Peripheral Blood Stem Cell Rescue for (A) Primary Resistant High Risk Neuroblastoma and (B) Relapsed Stage 4 Neuroblastoma

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.

OBJECTIVES:

  • Determine response (partial and complete response at metastatic sites) in children with relapsed stage 4 neuroblastoma or primary resistant high-risk neuroblastoma treated with high-dose iodine I 131 metaiodobenzylguanidine, topotecan hydrochloride, and peripheral blood stem cell transplantation.
  • Determine the proportion of patients who, as a result of this treatment, are able to progress to potentially curative surgery and further systemic treatment.
  • Correlate tumor dosimetry (to determine whether the tumor absorbed the radiation dose) with response in patients treated with this regimen.
  • Determine the time to tumor progression.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease type (relapsed stage 4 vs primary resistant high-risk neuroblastoma).

Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 and 15-19 and high-dose iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 30 minutes on days 1 and 15. Patients receive autologous CD 34+ peripheral blood stem cells when ^131I-MIBG dosimetry levels reach an acceptable low on days 25-29.

Total whole-body absorbed dose is measured periodically after the first ^131I-MIBG dose is administered and periodically thereafter.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 67 patients will be accrued for this study.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Neuroblastoma
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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July 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of neuroblastoma meeting the 1 of the following criteria:

    • Primary resistant high-risk disease meeting the following criteria:

      • International neuroblastoma staging system (INSS) stage 4, or stage 2 or 3 with myelocytomatosis viral-related oncogene (MycN) amplification
      • Failed to achieve satisfactory remission with induction chemotherapy, defined as one of the following:

        • Less than 50% reduction or > 3 positive sites on iodine I 131 metaiodobenzylguanidine (^131I-MIBG) scintigraphy
        • Persistent cytomorphological positive disease in bone marrow aspirates or trephine biopsies
        • Progressive disease necessitating a change of treatment
    • Relapsed stage 4 disease meeting the following criteria:

      • High-risk neuroblastoma (INSS stage 4, or stage 2 or 3 with MycN amplification)
      • Relapsed after intensive treatment including high-dose chemotherapy and hematopoietic progenitor cell support

        • Patients may be entered at the time of relapse, or at any point subsequently after other treatments
  • ^131I-MIBG-positive disease on diagnostic scintigraphy
  • Peripheral blood stem cell harvest ≥ 300,000/mm³ CD 34+ cells
  • Enrolled in or has been treated on protocol SIOP-NB-2009 or a similar protocol

PATIENT CHARACTERISTICS:

  • Glomerular filtration rate ≥ 50 mL/min
  • Considered fit enough to undergo proposed study treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
1 Year to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00389766
CCLG-NB-2006-08, CDR0000508611, EU-20644, EUDRACT-2005-002089-13
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Children's Cancer and Leukaemia Group
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Study Chair: Mark N. Gaze, MD University College London Hospitals
National Cancer Institute (NCI)
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP