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A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma

7. februar 2012 opdateret af: Keryx / AOI Pharmaceuticals, Inc.
This is an open-label, multicenter, phase II trial, assessing the antitumor activity, and safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic glioma.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This open-label, multicenter, phase II trial will assess the antitumor activity and safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic glioma.

Forty-one to 104 evaluable patients with temozolomide-resistant anaplastic glioma will be enrolled in this study. Total accrual on this study will not exceed 116 patients. The patients will receive daily temozolomide on 5 consecutive days (days 1-5) along with bolus infusions of O6-BG on days 1, 3, and 5 and a continuous infusion of O6-BG beginning immediately after the first bolus infusion and continuing until immediately prior to the last bolus injection. Patients will be evaluated for AEs during the course of therapy. Patients may receive treatment at the same dose level until appearance of significant treatment-related toxicities, disease progression or withdrawal of consent.

Tumor response will be evaluated at the end of cycle 1, cycle 2 and then every two cycles for the duration of therapy, using physical and neurological examinations and diagnostic imaging.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90033
        • AOI Pharmaceuticals Investigative Site
    • Florida
      • Orlando, Florida, Forenede Stater, 32804
        • AOI Pharmaceuticals Investigative Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • AOI Pharmaceuticals Investigative Site
      • Evanston, Illinois, Forenede Stater, 60201
        • AOI Pharmaceuticals Investigative Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • AOI Pharmaceuticals Investigative Site
      • Louisville, Kentucky, Forenede Stater, 40202
        • AOI Pharmaceuticals Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 54407
        • AOI Pharmaceuticals Investigative Site
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • AOI Pharmaceuticals Investigative Site
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • AOI Pharmaceuticals Investigative Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
        • AOI Pharmaceuticals Investigative Site
      • Houston, Texas, Forenede Stater, 77024
        • AOI Pharmaceuticals Investigative Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • AOI Pharmaceuticals Investigative Site

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients with histologically documented anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or mixed anaplastic oligoastrocytoma).
  2. Temozolomide-resistant defined as patients who have progressed while receiving or within 8 weeks of completing the last dose of temozolomide.
  3. Disease progression >= 12 weeks after the completion of any radiotherapy.
  4. If patient received chemotherapy or an investigational agent as part of their prior therapy, the patient must recover from all toxicities (<= Grade 1) prior to enrollment on this protocol.
  5. Bi-dimensionally measurable disease on contrast-enhanced magnetic resonance imaging study (MRI) performed within two weeks of study drug administration.
  6. If patient received intratumoral chemotherapy or immunotherapy as part of their prior therapy then histological confirmation of recurrence is mandated.
  7. KPS >= 70%.

  8. The following laboratory results:

    • Absolute neutrophil count >= 1500 cells/microliter
    • Platelet count >= 100,000 cells/microliter
    • SGOT <= 2.5 x ULN
    • Serum creatinine <= 1.5 x ULN
  9. Signed informed consent approved by Institutional Review Board.
  10. If sexually active, patients will take contraceptive measures for the duration of the treatment.
  11. For patients on corticosteroids, they must have been on a stable dose 1 week prior to baseline MRI and the dose should not be escalated over entry dose level, if clinically possible.

Exclusion Criteria:

  1. Pregnant or breast feeding women.
  2. Prior treatment with O6-BG plus temozolomide in combination.
  3. Active infection requiring intravenous antibiotics.
  4. Known diagnosis of Human Immunodeficiency Virus (HIV) infection (HIV testing is not mandatory).
  5. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
  6. Patients unwilling or unable to comply with the protocol.
  7. Patients who have received stereotactic radiosurgery or brachytherapy as part of their prior therapy.
  8. Comedication that may interfere with study results; eg. immunosuppressive agents other than corticosteroids.

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
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Temozolomide + O6BG
Medicin: Temozolomide and O6-Benzylguanine
O6BG + Temozolomide
Andre navne:
  • temodar

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
best objective response rate
Tidsramme: Month 1, 2 and every 2 months thereafter.
Month 1, 2 and every 2 months thereafter.

Sekundære resultatmål

Resultatmål
Tidsramme
Safety Assessment
Tidsramme: Month 1, 2 and every 2 months thereafter
Month 1, 2 and every 2 months thereafter
progression-free survival
Tidsramme: every 6 months
every 6 months
overall survival
Tidsramme: every 6 months
every 6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Keryx / AOI Pharmaceuticals, Inc.

Efterforskere

  • Studiestol: Jennifer Quinn, MD, Preston Robert Tisch Brain Tumor Center at Duke

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. oktober 2006

Primær færdiggørelse (Faktiske)

1. juni 2008

Studieafslutning (Faktiske)

1. februar 2009

Datoer for studieregistrering

Først indsendt

16. oktober 2006

Først indsendt, der opfyldte QC-kriterier

16. oktober 2006

Først opslået (Skøn)

18. oktober 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. februar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. februar 2012

Sidst verificeret

1. februar 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • O6BG 202

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 .

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