131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00293319
First received: February 16, 2006
Last updated: May 9, 2009
Last verified: March 2006
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Radioactive drugs, such as 131 I-MIBG, may carry radiation directly to tumor cells and not harm normal cells.
PURPOSE: This phase II trial is studying how well 131 I-MIBG works in treating patients with refractory or relapsed neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Biological: filgrastim Radiation: iobenguane I 131 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy [ Designated as safety issue: No ]
- Acute and late toxicities [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Disease and symptom responses [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2005 |
OBJECTIVES:
Primary
- Determine if iodine I 131 metaiodobenzylguanidine can provide palliative therapy for patients with refractory or relapsed neuroblastoma.
- Determine the acute and late toxicity of this regimen in these patients.
Secondary
- Determine disease and symptom responses of patients treated with this regimen.
OUTLINE: This is a compassionate use study.
Patients receive iodine I 131 metaiodobenzylguanidine IV over 2 hours. Beginning 10 days later, patients with low neutrophil counts receive filgrastim (G-CSF) subcutaneously until blood count recovers. Patients with stable or responding disease may receive a second dose of iodine I 131 metaiodobenzylguanidine at least 6 weeks after the first dose.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Original diagnosis of neuroblastoma based on 1 of the following criteria:
- Histopathology
- Elevated urine catecholamines with typical tumor cells in the bone marrow
Refractory or relapsed disease, meeting 1 of the following criteria:
- Failure to respond to standard therapy (e.g., combination chemotherapy with or without radiotherapy and surgery)
- Evidence of disease progression (i.e., any new lesion or an increase in size of > 25% of a pre-existing lesion) at any time
- Evaluable disease by MIBG scan within 6 weeks of study entry
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Negative pregnancy test
- Bilirubin < 2 times normal
- AST/ALT ≤ 10 times normal
- Creatinine ≤ 2 mg/dL
- Absolute neutrophil count* ≥ 750/mm^3 (transfusion independent)
- Platelet count* ≥ 50,000/mm^3 (20,000/mm^3 if stem cells are available and platelet transfusion independent)
- Hemoglobin* ≥ 10 g/dL (transfusion allowed)
- No dyspnea at rest
- No exercise intolerance
- No oxygen requirement
- No clinically significant cardiac dysfunction
- No disease of any major organ system that would preclude study compliance
- No active infection that meets grade 3 or 4 toxicity criteria NOTE: *Patients with granulocytopenia and/or thrombocytopenia due to tumor metastases to the bone marrow may be eligible at the discretion of the principal investigator
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- At least 2 weeks since prior antitumor therapy
At least 3 months since prior radiotherapy to any of the following fields:
- Craniospinal
- Total abdominal
- Whole lung
- Total body
- At least 1 day since prior cytokine therapy (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], interleukin-6, or epoetin alfa)
- Prior iodine I 131 metaiodobenzylguanidine allowed provided it was given more than 6 months ago AND patient has adequate hematopoietic stem cells available
- No concurrent hemodialysis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293319
Locations
| United States, California | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Study Chair: | Katherine K. Matthay, MD | University of California, San Francisco |
| Investigator: | John M. Maris, MD | Children's Hospital of Philadelphia |
| Investigator: | Robert Goldsby, MD | University of California, San Francisco |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00293319 History of Changes |
| Other Study ID Numbers: | CDR0000454716, UCSF-05161, UCSF-00161 |
| Study First Received: | February 16, 2006 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent neuroblastoma |
Additional relevant MeSH terms:
|
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 |
3-Iodobenzylguanidine Lenograstim Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013