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Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma

30. oktober 2013 opdateret af: Memorial Sloan Kettering Cancer Center

Monoclonal Antibody 3F8 and Oral Etoposide for the Treatment of Neuroblastoma

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus etoposide in treating patients who have neuroblastoma.

Studieoversigt

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the antitumor effects of monoclonal antibody 3F8, etoposide, and isotretinoin using standard imaging methods and tumor marker studies in patients with high-risk neuroblastoma.
  • Assess progression-free survival in these patients after this treatment.
  • Assess the effects of oral etoposide on human anti-mouse antibody and anti-idiotype response in these patients.

OUTLINE: Patients are stratified according to disease status (evaluable but not measurable vs second or subsequent remission with no measurable or evaluable disease).

Patients receive monoclonal antibody 3F8 (MOAB 3F8) IV over 1.5 hours once daily on days 1-10 and oral etoposide once daily on days 29-49. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression, human anti-mouse antibody (HAMA) response, or unacceptable toxicity.

If HAMA fails to develop after completion of 4 courses of MOAB 3F8, patients continue treatment with MOAB 3F8 on days 1-5 every 8 weeks until HAMA reaches greater than 1,000 U/mL or until month 24, whichever occurs first.

Beginning after completion of 4 courses of etoposide and MOAB 3F8 or if HAMA develops, patients receive oral isotretinoin twice daily for 14 days followed by at least a 14-day rest. Treatment repeats for a total of 6 courses.

PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study within 5 years.

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New York
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan-Kettering Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • High-risk neuroblastoma by:

    • Histopathology OR
    • Bone marrow involvement plus elevated urinary catecholamines
  • Prior tumor progression on standard chemotherapy and poor long-term prognosis as indicated by 1 or more of the following:

    • N-myc amplification in tumor cells
    • Diploid chromosomal content plus lp loss of heterozygosity in tumor cells
    • Distant skeletal metastases
    • Unresectable primary tumor infiltrating across the midline
    • More than 10% tumor cells in bone marrow
    • Less than 30% chance of long-term progression-free survival
  • Evaluable (microscopic marrow metastasis, elevated tumor markers, abnormal bone scan or MIBG or PET scan) but not measurable (CT scan, MRI) disease documented at least 4 weeks after completion of prior systemic therapy
  • No rapidly progressive disease as defined by 1 or more of the following:

    • Serum lactic dehydrogenase greater than 1.5 times upper limit of normal due to tumor
    • An opiate requirement for pain from tumor
    • Greater than 25% increase in tumor by successive imaging studies
    • Life expectancy less than 8 weeks
  • Second or subsequent remission after chemotherapy and/or radiotherapy allowed provided there is less than 30% chance of survival
  • No prior myelodysplastic syndromes or leukemia

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • See Disease Characteristics
  • At least 8 weeks

Hematopoietic:

  • Not specified

Hepatic:

  • No grade 3 or worse liver toxicity

Renal:

  • No grade 3 or worse renal toxicity
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No grade 3 or worse cardiac toxicity

Pulmonary:

  • No grade 3 or worse pulmonary toxicity

Other:

  • Not pregnant
  • No grade 3 or worse gastrointestinal toxicity
  • No grade 3 or worse neurologic system toxicity
  • No grade 4 hearing deficit
  • No active life-threatening infection
  • No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL
  • No allergy to mouse proteins

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Maskning: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 1999

Primær færdiggørelse (Faktiske)

1. september 2004

Datoer for studieregistrering

Først indsendt

10. december 1999

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. oktober 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Neuroblastom

Kliniske forsøg med etoposid

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