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

NCT00475150 | Completed Phase 2 Results

• 7 other identifiers: NCI-2009-00129CDR0000544833MCCRC-MC048HMC048H7135N01CM62205P30CA015083
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The Number of Confirmed Disease Response: Complete Response (CR), Partial Response (PR), and Hematologic Improvement (HI). A Confirmed Response is Defined to be an Objective Status of CR, PR, or HI Noted on 2 Consecutive Evaluations.

  Complete Response (CR) requires a repeat bone marrow with \< 5% myeloblasts, hemoglobin ≥ 11 g/dl, neutrophils ≥ 1000/mm3, platelets ≥ 100,000/mm3, and no circulating blasts. Partial Response (PR) requires a bone marrow blast reduction of 50% or more, hemoglobin ≥ 11 g/dl, neutrophils ≥ 1000/mm3, platelets ≥ 100,000/mm3, and no circulating blasts. Hematologic Improvement (HI) requires one of the following: 1. RBC transfusion independent participants are required to have \>1.5 g/dL increase in hemoglobin, 2. RBC transfusion-dependent participants are required to be transfusion independent, 3. A 100% increase, and an absolute increase over 500mm\^3 in Absolute Neutrophil Count, 4. Participants with a pretreatment platelet count over 20,000/mm3 require an absolute increase of 30,000/mm\^3 or more, 5. Participants with platelet count below 20,000/mm3 require an increase over 20,000/mm\^3 and by at least 100%.

  At the end of cycles 1 and 3 and every 3 cycles thereafter up to 26 cycles

Secondary Outcomes (4)

• Overall Survival

  Every cycle during treatment and every 6 months for up to 2 years after completion of study treatment

• Progression-free Survival

  Every 3 courses during treatment and then at 3 months and every 6 months for up to 2 years after completion of study treatment

• Duration of Response

  Every 3 courses up to 26 courses

• The Number of Patients That Report Adverse Events Possibly, Probably, or Definitely Related to AZD2171.

  Continuously during treatment up to 26 courses

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

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: laboratory biomarker analysis

Interventions

cediranib maleate DRUG

Given orally

Also known as: AZD2171, Recentin

Treatment (enzyme inhibitor therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (enzyme inhibitor therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (5)

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Congenital Abnormalities; Leukemia, Myeloid, Acute

Interventions

cediranib

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Mark B. Juckett, MD
• Organization: University of Wisconsin Comprehensive Cancer Center

mbj@medicine.wisc.edu

Study Officials

• Mark Juckett

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: May 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: March 1, 2012
• Last Updated: February 15, 2017
• Results First Posted: July 10, 2013

Record last verified: 2016-12

Locations

US (5)