NCT00622414

Brief Summary

This phase I trial is studying the side effects and best dose of aflibercept in treating young patients with relapsed or refractory solid tumors. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Last Updated

February 24, 2014

Status Verified

October 1, 2011

Enrollment Period

1.8 years

First QC Date

February 22, 2008

Last Update Submit

February 21, 2014

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose, defined as the maximum dose at which fewer than one-third of patients experience DLT during the initial 2 courses of therapy, graded according to NCI CTCAE version 3.0

    Up to 28 days

Study Arms (1)

Treatment (ziv-aflibercept)

EXPERIMENTAL

PART 1: Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days for 2 years in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive aflibercept until the maximum tolerated dose (MTD) is determined. PART 2: Patients receive aflibercept as in part 1 at 150% of the MTD determined in part 1. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.

Biological: ziv-aflibercept

Interventions

ziv-afliberceptBIOLOGICAL

Given IV

Also known as: aflibercept, vascular endothelial growth factor trap, VEGF Trap, Zaltrap
Treatment (ziv-aflibercept)

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically confirmed malignancy at original diagnosis or relapse (excluding intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of serum alpha-fetoprotein of beta-HCG)
  • Patients with recurrent or refractory solid tumors are eligible, including primary CNS tumors or patients with known CNS metastases
  • Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
  • Measurable or evaluable disease
  • No evidence of CNS hemorrhage on baseline MRI for patients with known CNS disease
  • Karnofsky performance status (PS) 50-100% (for patients \> 10 years of age) or Lansky PS 50-100% (for patients ≤ 10 years of age)
  • Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study entry
  • Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
  • Patients with solid tumors without bone marrow involvement must meet the following criteria:
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³ (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
  • Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
  • Negative protein dipstick OR urine protein \< 500 mg by 24-hour urine collection
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
  • mg/dL for male and female patients 1 to \< 2 years of age
  • +49 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60614, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Interventions

aflibercept

Study Officials

  • Julie Park

    COG Phase I Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2008

First Posted

February 25, 2008

Study Start

April 1, 2008

Primary Completion

February 1, 2010

Last Updated

February 24, 2014

Record last verified: 2011-10

Locations

US(6)