- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00389090
A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 90033
- AOI Pharmaceuticals Investigative Site
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Florida
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Orlando, Florida, Forente stater, 32804
- AOI Pharmaceuticals Investigative Site
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Illinois
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Chicago, Illinois, Forente stater, 60611
- AOI Pharmaceuticals Investigative Site
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Evanston, Illinois, Forente stater, 60201
- AOI Pharmaceuticals Investigative Site
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Kentucky
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Lexington, Kentucky, Forente stater, 40536
- AOI Pharmaceuticals Investigative Site
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Louisville, Kentucky, Forente stater, 40202
- AOI Pharmaceuticals Investigative Site
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Minnesota
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Minneapolis, Minnesota, Forente stater, 54407
- AOI Pharmaceuticals Investigative Site
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- AOI Pharmaceuticals Investigative Site
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South Carolina
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Greenville, South Carolina, Forente stater, 29605
- AOI Pharmaceuticals Investigative Site
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Texas
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Dallas, Texas, Forente stater, 75246
- AOI Pharmaceuticals Investigative Site
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Houston, Texas, Forente stater, 77024
- AOI Pharmaceuticals Investigative Site
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Utah
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Salt Lake City, Utah, Forente stater, 84132
- AOI Pharmaceuticals Investigative Site
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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:
- Patients with histologically documented anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or mixed anaplastic oligoastrocytoma).
- Temozolomide-resistant defined as patients who have progressed while receiving or within 8 weeks of completing the last dose of temozolomide.
- Disease progression >= 12 weeks after the completion of any radiotherapy.
- 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.
- Bi-dimensionally measurable disease on contrast-enhanced magnetic resonance imaging study (MRI) performed within two weeks of study drug administration.
- If patient received intratumoral chemotherapy or immunotherapy as part of their prior therapy then histological confirmation of recurrence is mandated.
- KPS >= 70%.
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
- Signed informed consent approved by Institutional Review Board.
- If sexually active, patients will take contraceptive measures for the duration of the treatment.
- 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:
- Pregnant or breast feeding women.
- Prior treatment with O6-BG plus temozolomide in combination.
- Active infection requiring intravenous antibiotics.
- Known diagnosis of Human Immunodeficiency Virus (HIV) infection (HIV testing is not mandatory).
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
- Patients unwilling or unable to comply with the protocol.
- Patients who have received stereotactic radiosurgery or brachytherapy as part of their prior therapy.
- Comedication that may interfere with study results; eg. immunosuppressive agents other than corticosteroids.
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 |
---|---|
Eksperimentell: Temozolomide + O6BG
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O6BG + Temozolomide
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
best objective response rate
Tidsramme: Month 1, 2 and every 2 months thereafter.
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Month 1, 2 and every 2 months thereafter.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Safety Assessment
Tidsramme: Month 1, 2 and every 2 months thereafter
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Month 1, 2 and every 2 months thereafter
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progression-free survival
Tidsramme: every 6 months
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every 6 months
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overall survival
Tidsramme: every 6 months
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every 6 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Jennifer Quinn, MD, Preston Robert Tisch Brain Tumor Center at Duke
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (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
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer, kjertel og epitel
- Neoplasmer, Neuroepithelial
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Glioma
- Astrocytom
- Oligodendrogliom
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Temozolomid
- O(6)-benzylguanin
Andre studie-ID-numre
- O6BG 202
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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Hospital del Río HortegaFullførtGlioma | Glioblastom | Gliom av lav kvalitet | Gliom, ondartet | Gliom av høy kvalitetSpania
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Sabine Mueller, MD, PhDPacific Pediatric Neuro-Oncology ConsortiumRekrutteringGlioblastom | Ondartet gliom | Tilbakevendende glioblastom | Tilbakevendende ondartet gliom | Tilbakevendende grad III Gliom | Grad III GliomForente stater, Australia, Israel, Sveits
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National Cancer Institute (NCI)RekrutteringGlioma | Gliom av høy grad | Ondartet gliom | Gliomer | Gliom av lav gradForente stater
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Susan ChangGE Healthcare; Sigma-Aldrich; Phillips-MedisizeRekrutteringTilbakevendende WHO Grad III Gliom | WHO Grad III Gliom | WHO Grad II Gliom | Tilbakevendende gliom av grad II fra Verdens helseorganisasjon (WHO).Forente stater
Kliniske studier på Temozolomide and O6-Benzylguanine
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Duke UniversityNational Cancer Institute (NCI)FullførtSvulster i hjernen og sentralnervesystemetForente stater
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National Cancer Institute (NCI)AvsluttetSvulster i hjernen og sentralnervesystemetForente stater
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Stanton Gerson MDNational Cancer Institute (NCI)Fullført
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Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)FullførtSvulster i hjernen og sentralnervesystemetForente stater
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