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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
New York
-
Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Maria R. Baer, MD, Roswell Park Cancer Institute
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- sekundær akut myeloid leukæmi
- tilbagevendende akut myeloid leukæmi hos voksne
- akut erythroid leukæmi hos voksne (M6)
- akut megakaryoblastisk leukæmi hos voksne (M7)
- voksen akut minimalt differentieret myeloid leukæmi (M0)
- akut monoblastisk leukæmi hos voksne (M5a)
- akut monocytisk leukæmi hos voksne (M5b)
- akut myeloblastisk leukæmi hos voksne med modning (M2)
- voksen akut myeloblastisk leukæmi uden modning (M1)
- akut myelomonocytisk leukæmi hos voksne (M4)
- blastisk fase kronisk myelogen leukæmi
- recidiverende kronisk myelogen leukæmi
- Philadelphia kromosom positiv kronisk myelogen leukæmi
- akut promyelocytisk leukæmi hos voksne (M3)
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Knoglemarvssygdomme
- Hæmatologiske sygdomme
- Myeloproliferative lidelser
- Leukæmi
- Leukæmi, myeloid
- Leukæmi, Myeloid, Akut
- Leukæmi, myelogen, kronisk, BCR-ABL positiv
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Topoisomerasehæmmere
- Topoisomerase I-hæmmere
- Irinotecan
- Cytarabin
Andre undersøgelses-id-numre
- CDR0000269286
- P30CA016056 (U.S. NIH-bevilling/kontrakt)
- RPCI-RPC-9901
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