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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000508611 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20644 | |||
| EUDRACT-2005-002089-13 |
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Withdrawn because protocol has been discontinued. It was never opened.
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iodine I 131 metaiodobenzylguanidine | Drug | |||
| topotecan hydrochloride | Drug | |||
| chemotherapy | Procedure | |||
| peripheral blood stem cell transplantation | Procedure | |||
| radioisotope therapy | Procedure | |||
| radionuclide imaging | Procedure | |||
| radiosensitization | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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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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:
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
^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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Mark N. Gaze, MD | University College London Hospitals | Study Chair |
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| total-body irradiation | Procedure |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D019797 | 3-Iodobenzylguanidine |
| D019772 | Topotecan |
| D004358 | Drug Therapy |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D007462 | Iodobenzenes |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006847 | Hydrocarbons, Iodinated |
| D006846 | Hydrocarbons, Halogenated |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| D008919 | Investigative Techniques |
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