Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

Phase II Study of Imatinib Mesylate (Gleevec, STI-571) (NSC#716051) and Decitabine (5-AZA-2'-Deoxycitidine) (NSC#127716), in Chronic Myelogenous Leukemia in Accelerated and Blastic Phases

Sponsoren

Hauptsponsor: National Cancer Institute (NCI)

Quelle National Cancer Institute (NCI)
Kurze Zusammenfassung

This phase II trial is studying how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving imatinib mesylate together with decitabine may kill more cancer cells

detaillierte Beschreibung

OBJECTIVES:

I. Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine.

II. Determine the survival rate of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Determine the effects of this regimen on gene methylation in the leukemic cells of these patients.

OUTLINE: Patients are stratified according to prior exposure to imatinib mesylate (yes vs no).

Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 20-80 patients (10-40 per stratum) will be accrued for this study within 20 months.

Gesamtstatus Completed
Anfangsdatum January 2003
Primäres Abschlussdatum May 2007
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Complete and partial response 6 months
Hematologic improvement Up to 1 year
Duration of response Date of documented response until relapse, assessed up to 4 years
Sekundäres Ergebnis
Messen Zeitfenster
Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Up to 4 years
Einschreibung 80
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: imatinib mesylate

Beschreibung: Given orally

Armgruppenetikett: Treatment (imatinib mesylate, decitabine)

Interventionsart: Drug

Interventionsname: decitabine

Beschreibung: Given IV

Armgruppenetikett: Treatment (imatinib mesylate, decitabine)

Interventionsart: Other

Interventionsname: laboratory biomarker analysis

Beschreibung: Correlative studies

Armgruppenetikett: Treatment (imatinib mesylate, decitabine)

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Histologically confirmed chronic myelogenous leukemia

- Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization

- Accelerated or non-lymphoid blastic phase

- Performance status - ECOG 0-2

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- AST no greater than 2 times ULN

- Creatinine less than 2.0 mg/dL

- Normal cardiac function

- No New York Heart Association class III or IV heart disease

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior decitabine

- At least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered

- Concurrent hydroxyurea allowed during the first 2 courses of study therapy in patients with rapidly progressing disease

- Prior imatinib mesylate allowed

- Patients who received at least 4 weeks of prior imatinib mesylate must have failed therapy, as evidenced by resistance after 8 weeks or disease progression

- No concurrent grapefruit or grapefruit juice

Geschlecht: All

Mindestalter: N/A

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Jean-Pierre Issa Principal Investigator M.D. Anderson Cancer Center
Ort
Einrichtung: M D Anderson Cancer Center
Standort Länder

United States

Überprüfungsdatum

January 2013

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 1
Armgruppe

Etikette: Treatment (imatinib mesylate, decitabine)

Art: Experimental

Beschreibung: Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.

Studiendesign Info

Zuweisung: N/A

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov