- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
- Kronisk myelomonocytisk leukemi
- Återkommande akut myeloid leukemi hos vuxna
- Akut myeloid leukemi hos vuxna med 11q23 (MLL) avvikelser
- Vuxen akut myeloid leukemi med Inv(16)(p13;q22)
- Akut myeloid leukemi hos vuxna med t(16;16)(p13;q22)
- Akut myeloid leukemi hos vuxna med t(8;21)(q22;q22)
- Sekundär akut myeloid leukemi
- Tidigare behandlade myelodysplastiska syndrom
- Återkommande akut lymfatisk leukemi hos vuxna
- Återfallande kronisk myelogen leukemi
- Sekundära myelodysplastiska syndrom
- Akut myeloid leukemi hos vuxna med t(15;17)(q22;q12)
- de Novo myelodysplastiska syndrom
- Eldfast anemi med överskott av sprängningar
- Blastisk fas kronisk myelogen leukemi
- Refraktär anemi med överskott av sprängningar i transformation
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
Texas
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Houston, Texas, Förenta staterna, 77030
- M D Anderson Cancer Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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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Korrelativa studier
Givet IV
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Maximum tolerated dose of becatecarin
Tidsram: 21 days
|
Graded using the NCI CTCAE version 3.0.
|
21 days
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Survival
Tidsram: From date of first study drug administration to the date of death of the patients, assessed up to 3 years
|
From date of first study drug administration to the date of death of the patients, assessed up to 3 years
|
Time to progression
Tidsram: 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
|
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
|
Time to treatment failure
Tidsram: 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
|
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
|
Duration of response
Tidsram: 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
|
Time to response
Tidsram: From the date of first study drug administration until the first objective documentation of response, assessed up to 3 years
|
From the date of first study drug administration until the first objective documentation of response, assessed up to 3 years
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Sjukdomsegenskaper
- Sjukdom
- Benmärgssjukdomar
- Hematologiska sjukdomar
- Myeloproliferativa störningar
- Neoplastiska processer
- Precancerösa tillstånd
- Myelodysplastiska-myeloproliferativa sjukdomar
- Celltransformation, neoplastisk
- Carcinogenes
- Syndrom
- Myelodysplastiska syndrom
- Leukemi
- Leukemi, myeloid
- Leukemi, Myeloid, Akut
- Neoplasma Metastas
- Upprepning
- Preleukemi
- Leukemi, myelomonocytisk, kronisk
- Leukemi, myelomonocytisk, juvenil
- Prekursorcellslymfoblastisk leukemi-lymfom
- Leukemi, lymfoid
- Anemi
- Leukemi, Myelogen, Kronisk, BCR-ABL positiv
- Blast Crisis
- Anemi, eldfast, med överskott av sprängningar
- Anemi, eldfast
Andra studie-ID-nummer
- NCI-2012-02609
- U01CA062461 (U.S.S. NIH-anslag/kontrakt)
- MDA-2003-0909
- CDR0000373813 (Registeridentifierare: PDQ (Physician Data Query))
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