Cediranib Maleate in Treating Patients With Relapsed, Refractory, or Untreated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
This phase II trial is studying how well cediranib maleate works in treating patients with relapsed, refractory, or untreated acute myeloid leukemia or high-risk myelodysplastic syndrome. Cediranib maleate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
de Novo Myelodysplastic Syndromes
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Untreated Adult Acute Myeloid Leukemia
Drug: cediranib maleate
Other: diagnostic laboratory biomarker analysis
Other: flow cytometry
Procedure: axillary lymph node biopsy
Procedure: histopathologic examination
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of AZD2171 in the Treatment of Patients With Acute Leukemia and Myelodysplastic Syndrome|
- Confirmed disease response [ Time Frame: At the end of courses 1 and 3 and every 3 courses thereafter ] [ Designated as safety issue: No ]Defined to be an objective status of CR, PR or HI noted on 2 consecutive evaluations.
- Survival [ Time Frame: Every 3 courses during treatment and then at 3 months and every 6 months for up to 2 years after completion of study treatment ] [ Designated as safety issue: No ]Defined as the time from date of registration to date of death due to any cause or date last known alive. The distribution of survival time will be estimated using the method of Kaplan-Meier.
- Time to disease progression [ Time Frame: Every 3 courses during treatment and then at 3 months and every 6 months for up to 2 years after completion of study treatment ] [ Designated as safety issue: No ]Defined as the time from date of registration to date that disease progression was documented or last date that progression-free status was documented. Estimated using the method of Kaplan-Meier.
- Duration of response [ Time Frame: Every 3 courses ] [ Designated as safety issue: No ]Measured from the time criteria are met for CR, PR, or HI (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Estimated using the method of Kaplan-Meier.
- Toxicity [ Time Frame: Continuously as they occur ] [ Designated as safety issue: Yes ]Graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|Study Start Date:||May 2008|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Drug: cediranib maleate
Other Names:Other: diagnostic laboratory biomarker analysis
Correlative studiesOther: flow cytometry
Correlative studiesProcedure: axillary lymph node biopsy
Other Name: axillary node biopsyProcedure: histopathologic examination
Other Name: Histopathology
I. Evaluate the objective response rate in patients with relapsed, refractory, or untreated acute myeloid leukemia or high-risk myelodysplastic syndromes treated with AZD2171 (cediranib maleate).
I. Determine the toxicity of this drug in these patients. II. Determine the response duration, event-free survival, and overall survival of patients treated with this drug.
III. Determine the hematological response rate in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (acute myeloid leukemia vs myelodysplastic syndromes).
Patients receive oral cediranib maleate once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy at baseline and on day 28 for correlative studies. Samples are analyzed for circulating endothelial cells, VEGF receptor expression, and leukemic blasts via flow cytometry and microvessel density via histopathological techniques.
After completion of study treatment, patients are followed up at 3 months and then every 6 months for up to 2 years.
|United States, District of Columbia|
|Howard University Hospital|
|Washington, District of Columbia, United States, 20060|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287-8936|
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48202|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Mark Juckett||Mayo Clinic|