- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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California
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Arcadia, California, Vereinigte Staaten, 91006-3776
- Children's Oncology Group
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Mündlich gegeben
Optionale korrelative Studien
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Response rate
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Levels of fenretinide
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Judith Villablanca, Children's Oncology Group
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Neubildungen nach histologischem Typ
- Neubildungen
- Neubildungen, Drüsen und Epithelien
- Krankheitsattribute
- Neubildungen, Neuroepithel
- Neuroektodermale Tumoren
- Neoplasmen, Keimzelle und Embryonal
- Neubildungen, Nervengewebe
- Neuroektodermale Tumore, primitiv
- Neuroektodermale Tumore, primitiv, peripher
- Wiederauftreten
- Neuroblastom
- Physiologische Wirkungen von Arzneimitteln
- Antineoplastische Mittel
- Schutzmittel
- Antikarzinogene Mittel
- Fenretinid
Andere Studien-ID-Nummern
- NCI-2012-01802 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- U10CA098543 (US NIH Stipendium/Vertrag)
- COG-ADVL0024
- COG-A0996
- CDR0000269408
- COG-ANBL0321
- ADVL0024 (Andere Kennung: Children's Oncology Group)
- ANBL0321 (Andere Kennung: CTEP)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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