A Multi-Center Phase 2 Study of VEGF Trap as a Single Agent in Acute Myeloid Leukemia

NCT00601991 | Withdrawn Phase 2 DMC

• 4 other identifiers: VICC HEM 0652P30CA068485VU-VICC-HEM-0652VU-VICC-061069
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Aflibercept may stop the growth of cancer cells by blocking blood flow to the cancer. PURPOSE: This phase II trial is studying how well aflibercept works in treating patients with advanced refractory, relapsed, or untreated acute myeloid leukemia.

Conditions

Leukemia

Keywords

untreated adult acute myeloid leukemia; recurrent adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

• Response rate of aflibercept

  As determined by the International Working Group: Complete response: bone marrow blast(BMB) percentage (%) \<=5% of nucleated cells and no detectable extramedullary disease; Partial response: BMB \>5% but decreased by at least 50% pre-treatment (pre-tx) value OR extramedullary disease still present; Stable disease: BMB \>5% and decreased or increased by \<50% of pre-tx value and no new extramedullary disease; Progressive disease: BMB \>=20% and an increase of at least 50% of pre-tx value and/or appearance of at least 50% in circulating blasts

  day 14 of cycle 4 (14-day cycle)

Secondary Outcomes (3)

• Bone marrow microvessel density determination at baseline, after courses 2 and 4 of treatment

  at baseline, at day 29 and at day 57

• Pharmacokinetics of free versus bound VEGF Trap

  Before and after 1st infusion on day 1, before infusion on day 1 of each 14-day cycle, and 60 days after last dose

• Progression-free survival in patients who achieve either a complete or partial response OR stable disease

  at 12 weeks

Interventions

VEGF Trap BIOLOGICAL

Drug under investigation

Also known as: Vascular endothelial growth factor trap

Bone marrow biopsy PROCEDURE

To determine response to treatment

bone marrow aspiration PROCEDURE

To determine response to treatment

Also known as: Removal of a sample of bone marrow using a needle

Venipuncture PROCEDURE

For test of free VEGF Trap compared to bound VEGF Trap and for routine clinical testing during treatment

Also known as: Taking blood sample

Eligibility Criteria

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

You may qualify if:

• ECOG performance status 0-2
• Life expectancy ≥ 60 days
• AST/ALT ≤ 2.5 times upper limit of normal (ULN)
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• Urine protein:creatinine ratio \< 1 OR 24-hour urine protein \< 500 mg
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception prior to, during, and for at least 6 months after completion of study therapy

You may not qualify if:

• Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• Serious or nonhealing wound, ulcer, or bone fracture
• History of allergic reactions attributed to compounds of similar chemical or biological composition to other agents used in the study
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment
• Clinically significant cardiovascular disease within the past 6 months, including any of the following:
• History of cerebrovascular accident
• Myocardial infarction, coronary artery bypass graft, or unstable angina
• New York Heart Association class III-IV congestive heart failure or serious cardiac arrhythmia requiring medication
• Clinically significant peripheral vascular disease
• Pulmonary embolism, deep venous thrombosis, or other thromboembolic event
• Uncontrolled hypertension, defined as BP \> 150/100 mm Hg, or systolic BP \> 180 mm Hg if diastolic blood pressure is \< 90 mm Hg, on at least 2 repeated determinations on separate days within the past 3 months
• Evidence of bleeding diathesis or coagulopathy
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
• Significant traumatic injury within 28 days prior to day 1 of therapy
• PRIOR CONCURRENT THERAPY:

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute

Interventions

aflibercept; Phlebotomy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Stephen Strickland, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine; Hematologist/Oncologist

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 28, 2008
• Study Start: March 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 2, 2013

Record last verified: 2013-03