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Sponsored by: |
Children's Cancer and Leukaemia Group |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00389766 |
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 | Intervention | 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 II |
MedlinePlus related topics: | Cancer Neuroblastoma Nuclear Scans |
ChemIDplus related topics: | Topotecan hydrochloride Topotecan Iodine Cadexomer iodine Sodium iodide I 131 3-Iodobenzylguanidine Iobenguane |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 67 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 1 Year to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Confirmed diagnosis of neuroblastoma meeting the 1 of the following criteria:
Primary resistant high-risk disease meeting the following criteria:
Failed to achieve satisfactory remission with induction chemotherapy, defined as one of the following:
Relapsed stage 4 disease meeting the following criteria:
Relapsed after intensive treatment including high-dose chemotherapy and hematopoietic progenitor cell support
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000508611, CCLG-NB-2006-08, EU-20644, EUDRACT-2005-002089-13 |
First Received: | October 18, 2006 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00389766 |
Health Authority: | Unspecified |
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