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

NCT00389766 | Withdrawn Phase 2

• 4 other identifiers: CCLG-NB-2006-08CDR0000508611EU-20644EUDRACT-2005-002089-13
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neuroblastoma

Keywords

localized unresectable neuroblastoma; recurrent neuroblastoma; regional neuroblastoma; localized resectable neuroblastoma; disseminated neuroblastoma

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

iodine I 131 metaiodobenzylguanidine DRUG

topotecan hydrochloride DRUG

chemotherapy PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radioisotope therapy PROCEDURE

radionuclide imaging PROCEDURE

radiosensitization PROCEDURE

total-body irradiation PROCEDURE

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

MeSH Terms

Conditions

Neuroblastoma

Interventions

3-Iodobenzylguanidine; Topotecan; Drug Therapy; Peripheral Blood Stem Cell Transplantation; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Iodobenzenes; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydrocarbons, Iodinated; Hydrocarbons, Halogenated; Camptothecin; Alkaloids; Heterocyclic Compounds; Therapeutics; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Transplantation; Surgical Procedures, Operative; Radiotherapy; Investigative Techniques

Study Officials

• Mark N. Gaze, MD

  University College London Hospitals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: July 1, 2008
• Primary Completion: July 1, 2008
• Last Updated: July 10, 2013

Record last verified: 2007-06