- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00053326
Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma
A Phase II Study of Fenretinide (NSC# 374551, IND# 40294) in Children With Recurrent/Resistant High Risk Neuroblastoma
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
Determine the response rate in pediatric patients with recurrent or resistant high-risk neuroblastoma treated with fenretinide.
Determine the toxic effects of this drug in these patients. Determine the proportion of patients with disease detected only by bone marrow immunocytology, who clear all evidence of disease during treatment with this drug.
Determine minimal residual disease response by marrow and meta-iodobenzylguanidine (MIBG) I 123 scan in patients treated with this drug.
OUTLINE: Patients are stratified according to presence of measurable disease on CT scan/MRI (yes vs no). A third stratum of patients with tumor cells in bone marrow by immunocytology only is enrolled but is not evaluated for response.
Patients receive oral fenretinide 3 times daily (or 2 times daily if over 18 years of age) on days 1-7. Treatment repeats every 3 weeks for up to 30 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum III who fail to achieve a complete response after 8 courses of therapy are removed from study.
Patients are followed monthly until blood counts and visual acuity are stable or normalized and then every 6 months for 2 years and annually for 3 years.
PROJECTED ACCRUAL: A total of 70 patients (25 each for strata I and II, 20 for stratum III) will be accrued for this study within 1-2 years.
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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California
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Arcadia, California, Forente stater, 91006-3776
- Children's Oncology Group
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Diagnosis of recurrent or resistant/refractory high-risk neuroblastoma by one or both of the following:
- Histological confirmation
- Demonstration of tumor cells in bone marrow with increased urinary catecholamines
Stratum I:
At least 1 unidimensionally measurable lesion*
- At least 20 mm by MRI and/or CT scan OR at least 10 mm by spiral CT scan
Stratum II: Meets one or both of the following criteria:
- At least 1 site with positive uptake on meta-iodobenzylguanidine (MIBG) I 123 scan
- Tumor in bilateral bone marrow aspirate/biopsy by routine morphology (no NSE staining only)
Stratum III:
- At least 5 tumor cells/10^6 mononuclear cells in the bone marrow by immunocytology only (on 2 successive bone marrows performed from 1 day to 4 weeks apart)
- Patients in first response (i.e., patients with persistent tumor at end of frontline therapy, but who have never had disease relapse or progression) must have histological* or morphological (by bone marrow) confirmation** of viable tumor on CT scan, MRI, or MIBG scan after completion of myeloablative therapy (for strata I and II)
- No catecholamine elevation only
- Performance status - 0-2
- At least 2 months
- Hemoglobin greater than 7.5 g/dL (transfusion allowed)
- Bilirubin no greater than 1.5 times normal
- SGPT and SGOT less than 2.5 times normal
- Creatinine normal for age
- No hematuria or proteinuria greater than 1+ on urinalysis
- Calcium less than 11.6 mg/dL
- Triglycerides less than 300 mg/dL
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No seizure disorders unless on anticonvulsants and well controlled
- No skin toxicity greater than grade 1
- Must be able to consume entire intact study capsule in the dosage prescribed for body surface area
- Recovered from prior immunotherapy
- At least 7 days since prior anticancer biologic therapy
- At least 2 days since prior growth factors
- Prior autologous stem cell transplantation allowed
- No prior allogeneic stem cell transplantation
- No concurrent immunomodulating agents
- At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
- No concurrent anticancer chemotherapy
- No concurrent steroids
- Recovered from prior radiotherapy
- At least 4 weeks since prior radiotherapy to target lesion
- Prior radiotherapy to non target lesions allowed
- No concurrent radiotherapy to sole measurable lesion for symptom relief
- Concurrent palliative radiotherapy to non target or localized painful lesions allowed
- Prior tretinoin or isotretinoin allowed
- At least 2 weeks since other prior retinoids
- No prior fenretinide
- No concurrent supplemental oral or IV vitamin A, ascorbic acid, or vitamin E (except if contained in routine total parenteral nutrition [TPN] vitamin supplements)
- No concurrent drugs suspected of causing pseudotumor cerebri (e.g., tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, amiodarone, or vitamin A [except as part of routine TPN supplements])
- No other concurrent anticancer agents
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Treatment (fenretinide)
Patients receive oral fenretinide 3 times daily (or 2 times daily if over 18 years of age) on days 1-7.
Treatment repeats every 3 weeks for up to 30 courses in the absence of disease progression or unacceptable toxicity.
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Gis muntlig
Valgfrie korrelative studier
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Response rate
Tidsramme: Up to 8 courses of therapy
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A responder is defined to be a patient who achieves a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR).
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Up to 8 courses of therapy
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Toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Tidsramme: Up to 5 years
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Assessed via a descriptive tabulation of the toxicity rates, overall and by stratum.
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Up to 5 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Levels of fenretinide
Tidsramme: At baseline and during courses 1, 2, and 5
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Assessed via descriptive analysis of the steady state levels of fenretinide overall and by stratum
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At baseline and during courses 1, 2, and 5
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Plasma retinol levels
Tidsramme: At baseline and during courses 1, 2, and 5
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Assessed via descriptive analysis of the plasma retinol levels overall and by stratum.
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At baseline and during courses 1, 2, and 5
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Minimal residual disease (MRD) (Stratum 3)
Tidsramme: Up to 5 years
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Assessed by descriptive calculation of the proportion of responders.
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Up to 5 years
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Judith Villablanca, Children's Oncology Group
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer, kjertel og epitel
- Sykdomsattributter
- Neoplasmer, Neuroepithelial
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Neuroektodermale svulster, primitive
- Neuroektodermale svulster, primitive, perifere
- Tilbakefall
- Nevroblastom
- Fysiologiske effekter av legemidler
- Antineoplastiske midler
- Beskyttende agenter
- Antikreftfremkallende midler
- Fenretinid
Andre studie-ID-numre
- NCI-2012-01802 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- U10CA098543 (U.S. NIH-stipend/kontrakt)
- COG-ADVL0024
- COG-A0996
- CDR0000269408
- COG-ANBL0321
- ADVL0024 (Annen identifikator: Children's Oncology Group)
- ANBL0321 (Annen identifikator: CTEP)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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