- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00087204
Rebeccamycin Analog in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia
A Phase I Study Of XL119 In Patients With Relapsed Or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphocytic Leukemia, Or Chronic Myeloid Leukemia In Blastic-Phase
Studieoversikt
Status
Forhold
- Kronisk myelomonocytisk leukemi
- Tilbakevendende akutt myeloid leukemi hos voksne
- Akutt myeloid leukemi hos voksne med 11q23 (MLL) abnormiteter
- Akutt myeloid leukemi for voksne med Inv(16)(p13;q22)
- Akutt myeloid leukemi hos voksne med t(16;16)(p13;q22)
- Akutt myeloid leukemi hos voksne med t(8;21)(q22;q22)
- Sekundær akutt myeloid leukemi
- Tidligere behandlede myelodysplastiske syndromer
- Tilbakevendende akutt lymfatisk leukemi hos voksne
- Tilbakevendende kronisk myelogen leukemi
- Sekundære myelodysplastiske syndromer
- Akutt myeloid leukemi hos voksne med t(15;17)(q22;q12)
- de Novo myelodysplastiske syndromer
- Ildfast anemi med overflødig eksplosjon
- Blastisk fase kronisk myelogen leukemi
- Ildfast anemi med overskytende eksplosjoner i transformasjon
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
I. Determine the maximum tolerated dose and dose-limiting toxicity of rebeccamycin analogue (XL119) in patients with relapsed or refractory acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blastic phase.
OUTLINE: This is a dose-escalation study.
Patients receive rebeccamycin analogue (XL119) IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 1 additional course beyond CR. Patients achieving a partial response (PR) or hematologic improvement (HI) receive 2 additional courses beyond PR or HI. Cohorts of 3-6 patients receive escalating doses of XL119 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
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Texas
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Houston, Texas, Forente stater, 77030
- M D Anderson Cancer Center
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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 1 of the following:
- Acute myeloid leukemia
Myelodysplastic syndromes, including 1 of the following:
- Refractory anemia with excess blasts (RAEB)
- RAEB in transformation
- Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood or bone marrow blasts
- Acute lymphoblastic leukemia
- Chronic myelogenous leukemia in blastic phase
Relapsed or refractory disease, defined as 1 of the following:
- Failed to achieve a complete response (CR) to a standard induction regimen
- Relapsed after achieving a CR
- Failed last cytotoxic regimen before study entry
- No alternate, potentially curative option available
- No known CNS disease
- Performance status - ECOG 0-2
- SGOT and SGPT normal
- Bilirubin normal
- Creatinine normal
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV-positive patients with normal CD4 count and without AIDS-defining disease allowed
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue (XL119)
- No concurrent uncontrolled illness
- No active or ongoing infection
- No psychiatric illness or social situation that would preclude study compliance
- No prior allogeneic stem cell transplantation
- No concurrent prophylactic hematopoietic colony-stimulating factors (CSF)
- No epoetin alfa or hematopoietic CSF during course 1 of study therapy
- More than 7 days since prior cytotoxic chemotherapy except for hydroxyurea
- More than 7 days since prior radiotherapy
- Recovered from all prior therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer agents or therapies
- No other concurrent antileukemic agents or therapies
- No other concurrent investigational agents or therapies
- No other concurrent cytotoxic 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 |
---|---|
Eksperimentell: Treatment (becatecarin)
Patients receive rebeccamycin analogue (XL119) IV over 1 hour on days 1-5.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a CR receive 1 additional course beyond CR.
Patients achieving a PR or HI receive 2 additional courses beyond PR or HI.
Cohorts of 3-6 patients receive escalating doses of XL119 until the MTD is determined.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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Korrelative studier
Gitt IV
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Maximum tolerated dose of becatecarin
Tidsramme: 21 days
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Graded using the NCI CTCAE version 3.0.
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21 days
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Survival
Tidsramme: From date of first study drug administration to the date of death of the patients, assessed up to 3 years
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From date of first study drug administration to the date of death of the patients, assessed up to 3 years
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Time to progression
Tidsramme: From the date of first study drug administration to the date that the patient is withdrawn because of clinical or radiographic progressive disease, or death from any cause, assessed up to 3 years
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From the date of first study drug administration to the date that the patient is withdrawn because of clinical or radiographic progressive disease, or death from any cause, assessed up to 3 years
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Time to treatment failure
Tidsramme: From the date of first study drug administration to the date of withdrawal from the study for any reason other than study closure, assessed up to 3 years
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From the date of first study drug administration to the date of withdrawal from the study for any reason other than study closure, assessed up to 3 years
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Duration of response
Tidsramme: From the date of first objective response to the date of progression, assessed up to 3 years
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From the date of first objective response to the date of progression, assessed up to 3 years
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Time to response
Tidsramme: From the date of first study drug administration until the first objective documentation of response, assessed up to 3 years
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From the date of first study drug administration until the first objective documentation of response, assessed up to 3 years
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Samarbeidspartnere og etterforskere
Sponsor
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
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Sykdomsattributter
- Sykdom
- Benmargssykdommer
- Hematologiske sykdommer
- Myeloproliferative lidelser
- Neoplastiske prosesser
- Forstadier til kreft
- Myelodysplastiske-myeloproliferative sykdommer
- Celletransformasjon, neoplastisk
- Karsinogenese
- Syndrom
- Myelodysplastiske syndromer
- Leukemi
- Leukemi, myeloid
- Leukemi, Myeloid, Akutt
- Neoplasma Metastase
- Tilbakefall
- Preleukemi
- Leukemi, myelomonocytisk, kronisk
- Leukemi, myelomonocytisk, juvenil
- Forløpercelle lymfoblastisk leukemi-lymfom
- Leukemi, lymfoid
- Anemi
- Leukemi, myelogen, kronisk, BCR-ABL positiv
- Blast krise
- Anemi, ildfast, med overskudd av eksplosjoner
- Anemi, ildfast
Andre studie-ID-numre
- NCI-2012-02609
- U01CA062461 (U.S. NIH-stipend/kontrakt)
- MDA-2003-0909
- CDR0000373813 (Registeridentifikator: PDQ (Physician Data Query))
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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