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
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| ClinicalTrials.gov Identifier: NCT00389766 |
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Recruitment Status :
Withdrawn
(Withdrawn because protocol has been discontinued. It was never opened.)
First Posted : October 19, 2006
Last Update Posted : July 10, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | July 2008 |
| Estimated Primary Completion Date : | July 2008 |
- 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
- Proportion of patients who are able to progress to potentially curative treatment with surgery and further systemic treatment
- Correlation of tumor dosimetry with response
- Time to tumor progression
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| Ages Eligible for Study: | 1 Year to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Confirmed diagnosis of neuroblastoma meeting the 1 of the following criteria:
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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
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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
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Relapsed stage 4 disease meeting the following criteria:
- High-risk neuroblastoma (INSS stage 4, or stage 2 or 3 with MycN amplification)
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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
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- ^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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389766
| Study Chair: | Mark N. Gaze, MD | University College London Hospitals |
| ClinicalTrials.gov Identifier: | NCT00389766 History of Changes |
| Other Study ID Numbers: |
CCLG-NB-2006-08 CDR0000508611 ( Registry Identifier: PDQ (Physician Data Query) ) EU-20644 EUDRACT-2005-002089-13 |
| First Posted: | October 19, 2006 Key Record Dates |
| Last Update Posted: | July 10, 2013 |
| Last Verified: | June 2007 |
Keywords provided by National Cancer Institute (NCI):
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localized unresectable neuroblastoma recurrent neuroblastoma regional neuroblastoma localized resectable neuroblastoma disseminated neuroblastoma |
Additional relevant MeSH terms:
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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 Iodine Topotecan 3-Iodobenzylguanidine |
Anti-Infective Agents, Local Anti-Infective Agents Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Radiopharmaceuticals |