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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00622414 |
RATIONALE: Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of aflibercept in treating young patients with relapsed or refractory solid tumors.
Condition | Intervention | Phase |
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Unspecified Childhood Solid Tumor, Protocol Specific |
Biological: aflibercept |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of VEGF Trap (NSC# 724770, IND# 100137) in Children With Refractory Solid Tumors |
Estimated Enrollment: | 27 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed for at least 30 days.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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)
PATIENT CHARACTERISTICS:
Karnofsky performance status (PS) 50-100% (for patients > 10 years of age) or Lansky PS 50-100% (for patients ≤ 10 years of age)
Patients with solid tumors without bone marrow involvement must meet the following criteria:
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
No clinically significant cardiovascular disease within the past 6 months, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Alabama | |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Clinical Trials Office - Lurleen Wallace Comprehensive Cancer 205-934-0309 | |
United States, California | |
Children's Hospital of Orange County | Recruiting |
Orange, California, United States, 92868 | |
Contact: Violet Shen 714-532-8636 | |
United States, Illinois | |
Children's Memorial Hospital - Chicago | Recruiting |
Chicago, Illinois, United States, 60614 | |
Contact: David O. Walterhouse 773-755-6514 | |
United States, Indiana | |
Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202-5289 | |
Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229-3039 | |
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-0161 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | Recruiting |
Memphis, Tennessee, United States, 38105 | |
Contact: Clinical Trials Office - St. Jude Children's Research Hospital 901-595-4644 | |
United States, Texas | |
Baylor University Medical Center - Houston | Recruiting |
Houston, Texas, United States, 77030-2399 | |
Contact: Alberto Pappo 832-822-4248 | |
United States, Washington | |
Children's Hospital and Regional Medical Center - Seattle | Recruiting |
Seattle, Washington, United States, 98105 | |
Contact: Douglas Hawkins 206-987-3096 |
Study Chair: | Julie R. Park, MD | Seattle Children's Hospital |
Principal Investigator: | Elizabeth Fox, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000584050, COG-ADVL0714, NCI-08-C-0179, NCI-P08401 |
Study First Received: | February 22, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00622414 History of Changes |
Health Authority: | Unspecified |
unspecified childhood solid tumor, protocol specific |