Clinical trial NCT00054431: Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Accelerated Phase Chronic Myelogenous Leukemia
Blastic Phase Chronic Myelogenous Leukemia
Childhood Chronic Myelogenous Leukemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Relapsing Chronic Myelogenous Leukemia
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-02-06
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete and partial response
timeFrame: 6 months
measure: Hematologic improvement
timeFrame: Up to 1 year
measure: Duration of response
timeFrame: Date of documented response until relapse, assessed up to 4 years
Secondary outcomes:
measure: Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jean-Pierre Issa
role: PRINCIPAL_INVESTIGATOR
References: