- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00293319
131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma
I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
California
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San Francisco, California, Forenede Stater, 94115
- UCSF Comprehensive Cancer Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0942
- University of Michigan Comprehensive Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Children's Hospital of Philadelphia
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy
|
Acute and late toxicities
|
Sekundære resultatmål
Resultatmål |
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Disease and symptom responses
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Katherine K. Matthay, MD, University of California, San Francisco
- John M. Maris, MD, Children's Hospital of Philadelphia
- Robert Goldsby, MD, University of California, San Francisco
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer, kirtel og epitel
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neuroektodermale tumorer, primitive
- Neuroektodermale tumorer, primitive, perifere
- Neuroblastom
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Radiofarmaceutiske præparater
- 3-iodbenzylguanidin
Andre undersøgelses-id-numre
- CDR0000454716
- UCSF-05161
- UCSF-00161
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-
Instituto de Investigacion Sanitaria La FeAfsluttetLAV OG MELLEMMIDDEL PÆDIATRISK NEUROBLASTOMA OG NEONATAL SUPRARENAL MASSERSpanien, Italien, Belgien, Danmark, Sverige, Norge, Israel, Schweiz, Australien, Østrig
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