Irinotecan and Cytarabine in Treating Patients With Refractory or Recurrent Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
Irinotecan And Cytarabine In Refractory or Relapsed Acute Myeloid Leukemia And In Chronic Myelogenous Leukemia In Myeloid Blast Transformation: Efficacy And In Vitro Correlates
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with cytarabine in treating patients who have refractory or recurrent acute myeloid leukemia or chronic myelogenous leukemia.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Determine the activity of irinotecan and cytarabine in patients with refractory or recurrent acute myeloid leukemia or chronic myelogenous leukemia in myeloid blast transformation.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the maximum tolerated dose of irinotecan in this regimen in these patients.
- Correlate the clinical activity of this drug with cellular endpoints associated with DNA synthesis inhibition, DNA repair, induction of apoptosis, and drug resistance in these patients.
OUTLINE: This is a dose-escalation study of irinotecan.
Patients receive irinotecan IV over 90 minutes and cytarabine IV over 60 minutes on days 1-6. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. An additional 9 patients with refractory/relapsed acute myeloid leukemia and 9 patients with chronic myelogenous leukemia in myeloid blast transformation are treated at the MTD.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 2.5 years.
Studietype
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
New York
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Buffalo, New York, Forente stater, 14263-0001
- Roswell Park Cancer Institute
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed acute myeloid leukemia (M0-M7)
De novo or secondary disease
- Previously treated and refractory to prior therapy (which has included high-dose cytarabine and an anthracycline)
- Antecedent hematologic disorders allowed OR
Histologically confirmed Philadelphia chromosome-positive chronic myelogenous leukemia in myeloid blast transformation
- Treated or untreated
- Blast transformation defined by at least 20% blasts in marrow and/or blood
- Myeloid lineage defined by immunophenotyping
PATIENT CHARACTERISTICS:
Age
- 15 and over
Performance status
- 0-3
Life expectancy
- At least 4 weeks
Hematopoietic
- See Disease Characteristics
Hepatic
- Bilirubin less than 2 times upper limit of normal (ULN)
- SGOT less than 2 times ULN
Renal
- Creatinine less than 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- No other concurrent serious medical or psychiatric illness that would preclude study consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- Prior chemotherapy for an antecedent malignancy or other medical condition allowed
Endocrine therapy
- Not specified
Radiotherapy
- Prior radiotherapy for an antecedent malignancy or other medical condition allowed
Surgery
- Not specified
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Maria R. Baer, MD, Roswell Park Cancer Institute
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
- sekundær akutt myeloid leukemi
- tilbakevendende akutt myeloid leukemi hos voksne
- akutt erytroid leukemi hos voksne (M6)
- akutt megakaryoblastisk leukemi hos voksne (M7)
- akutt minimalt differensiert myeloid leukemi (M0) hos voksne
- akutt monoblastisk leukemi hos voksne (M5a)
- akutt monocytisk leukemi hos voksne (M5b)
- akutt myeloblastisk leukemi hos voksne med modning (M2)
- voksen akutt myeloblastisk leukemi uten modning (M1)
- akutt myelomonocytisk leukemi hos voksne (M4)
- blastisk fase kronisk myelogen leukemi
- tilbakefallende kronisk myelogen leukemi
- Philadelphia kromosom positiv kronisk myelogen leukemi
- akutt promyelocytisk leukemi hos voksne (M3)
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Benmargssykdommer
- Hematologiske sykdommer
- Myeloproliferative lidelser
- Leukemi
- Leukemi, myeloid
- Leukemi, Myeloid, Akutt
- Leukemi, myelogen, kronisk, BCR-ABL positiv
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Topoisomerasehemmere
- Topoisomerase I-hemmere
- Irinotekan
- Cytarabin
Andre studie-ID-numre
- CDR0000269286
- P30CA016056 (U.S. NIH-stipend/kontrakt)
- RPCI-RPC-9901
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