Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy
Cilengitide (EMD 121974) (IND# 59073) in Recurrent or Progressive and Refractory Childhood High-Grade Glioma
5 other identifiers
interventional
30
2 countries
20
Brief Summary
This phase II trial studies how well cilengitide works in treating younger patients with recurrent or progressive high-grade glioma that has not responded to standard therapy. Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2008
Typical duration for phase_2
20 active sites
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
May 14, 2008
CompletedFirst Posted
Study publicly available on registry
May 16, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
February 20, 2014
CompletedAugust 1, 2018
July 1, 2018
2.3 years
May 14, 2008
January 6, 2014
July 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response to Cilengitide
Objective response is defined as a complete response or partial response at 4 weeks that is sustained for at least another 4 weeks, or a stable disease at 4 weeks that is sustained for at least 12 weeks while on stable or decreasing dose of corticosteroids, except when corticosteroids are being used to control hydrocephaly unrelated to tumor progression.
Up to 16 weeks
Secondary Outcomes (12)
Time to Tumor Progression (TTP)
Time from study enrollment to radiographically determined tumor progression or recurrence, assessed up to 5 years
Time to Treatment Failure (TTF)
Time from study enrollment to tumor progression, tumor recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up to 5 years
Time to Death (TTD)
Time from study enrollment to death from any cause, assessed up to 5 years
Rate of Toxicity, Especially That of Symptomatic Intratumoral Hemorrhage (ITH) Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Up to 5 years
Pharmacokinetic Parameter of Cilengitide in Plasma: Volume of Central Compartment (Vc)
At baseline and 1, 3, and 6 hours after the first dose of cilengitide
- +7 more secondary outcomes
Study Arms (1)
Treatment (cilengitide)
EXPERIMENTALPatients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Correlative studies
Eligibility Criteria
You may qualify if:
- Histologically confirmed primary central nervous system (CNS) high-grade glioma, including any of the following:
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- High-grade astrocytoma not otherwise specified (i.e., anaplastic ganglioglioma, anaplastic mixed glioma, or anaplastic mixed glioneuronal tumors)
- No diffuse pontine gliomas, gliomatosis cerebri, and primary spinal cord high-grade astrocytoma
- Gliosarcoma
- Recurrent or progressive disease that is refractory to standard therapy
- Radiographically documented measurable disease
- Lesion must be at least twice the thickness of the image from which it is derived (e.g., 10 mm for a 5 mm slice thickness)
- No diffuse pontine gliomas
- No evidence of prior CNS bleeding
- Karnofsky performance status (PS) 50-100% (patients \> 16 years of age)
- Lansky PS 50-100% (patients =\< 16 years of age)
- Life expectancy \>= 8 weeks
- +41 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
University of California San Francisco Medical Center-Parnassus
San Francisco, California, 94143, United States
Lombardi Comprehensive Cancer Center at Georgetown University
Washington D.C., District of Columbia, 20057, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60614, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Palmetto Health Richland
Columbia, South Carolina, 29203, United States
T C Thompson Children's Hospital
Chattanooga, Tennessee, 37403, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226, United States
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
Tobey MacDonald
Children's Oncology Group
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 14, 2008
First Posted
May 16, 2008
Study Start
June 1, 2008
Primary Completion
October 1, 2010
Study Completion
July 1, 2011
Last Updated
August 1, 2018
Results First Posted
February 20, 2014
Record last verified: 2018-07