Cediranib Maleate in Treating Patients With Relapsed, Refractory, or Untreated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00475150

Run by

National Cancer Institute (NCI)

People needed

39

Starts

2008-05-01

Expected to finish

2012-03-01

Last updated by the study team

2017-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed acute myeloid leukemia (AML) ormyelodysplastic syndromes meeting 1 of the following criteria:
• Relapsed AML meeting any of the following criteria:
• Good-risk cytogenetics (inv[16], t[8;21], or t[15;17]) in second orgreater relapse
• Patients with AML t(15;17) must have failed prior tretinoin and arsenic-containing regimens AND progressed orrelapsed within 12 months of therapy
• In first or greater relapse
• Resistant AML
• Unable to achieve first complete remission after at least 2 inductionregimens
• Untreated AML meeting any of the following criteria:
• At least 60 years of age
• Preceding MDS
• MDS
• International Prognosis Scoring System (IPSS) risk groupof intermediate-2 or higher
• Patients with relapsed disease after allogeneic hematopoietic stem cell transplantation (HSCT) must be off allimmunosuppressive medications for at least 30 days and have no symptoms orsigns of graft-vs-host disease
• No active CNS metastasis
• Patients with clinical signs of CNS disease or a history of CNS diseasewithin the past 6 months are required to undergo lumbar puncture to excludeCNS involvement
• No symptomatic leukostasis or requirement for leukapheresis
• Not eligible for allogeneic HSCTAND no suitable donor at the time of study entry
• Patients who areeligible for HSCT, informed of the option, and choose not to proceed to HSCTare allowed
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Bilirubin normal
• AST and/or ALT ≤ 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• No proteinuria ≥ 1+ on 2 consecutive urinalysis taken ≥ 1 week apart
• Not pregnant or nursing
• Negative pregnancy test

Where it is running

• Howard University Hospital — Washington D.C., District of Columbia, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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