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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cediranib; Maleic acid

Criteria

Inclusion Criteria:

• 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

• Fertile patients must use effective contraception

• No HIV positivity

• LVEF ≥ 45% by echocardiography

• Mean QTc ≤ 500 msec (with Bazett's correction)

• No other significant ECG abnormality

• No history of familial long QT syndrome

• No disseminated intravascular coagulation

• No history of allergic reactions attributed to compounds of similar chemical orbiological composition to AZD2171

• No concurrent uncontrolled illness, including, but not limited to, any of the following:

• Hypertension

• Thyroid disease

• Ongoing or active infection

• Symptomatic congestive heartfailure

• Unstable angina pectoris

• Cardiac arrhythmia

• NYHA class III-IV heart disease

• NYHA class II heart disease controlled with treatment allowed

• Psychiatric illness or social situations that would limit study compliance

• See Disease Characteristics

• More than 4 weeks since prior chemotherapy (6 weeks fornitrosoureas or mitomycin C), radiotherapy, or major surgery and recovered

• Hydroxyurea allowed to control peripheral blast count> 20,000/mcL prior to study entry and during the first 3 days of study therapy

• More than 4 weeks since prior and no concurrent growth factor or other cytokine support

• At least 30 days since prior investigational agents or participation in aninvestigational trial

• No more than 3 prior courses of induction chemotherapy

• Induction chemotherapyis defined as that intended to induce complete remission and given at a time thatthe patient has active disease

• No concurrent CYP interactive medications

• No other concurrent investigational agents

• No concurrent drugs or biologics with proarrhythmic potential

• Prior and concurrent hydroxyurea allowed to control peripheral blast count> 20,000/mcL during the first 3 days of study therapy