Trial · NCT00679354

Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy

NCT00679354, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-02-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy. Trials, record NCT00679354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00679354

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy
NCT number: NCT00679354
Status: Completed
Phases: Phase 2
Enrollment: 30 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Childhood High-grade Cerebellar Astrocytoma, Childhood High-grade Cerebral Astrocytoma, Recurrent Childhood Anaplastic Astrocytoma, Recurrent Childhood Anaplastic Oligoastrocytoma, Recurrent Childhood Anaplastic Oligodendroglioma, Recurrent Childhood Brain Tumor, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Glioblastoma, Recurrent Childhood Visual Pathway and Hypothalamic Glioma
Interventions: cilengitide, laboratory biomarker analysis, pharmacological study
First posted: 2008-05-16
Last updated: 2018-08-01
Results first posted: 2014-02-20

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response to Cilengitide	Up to 16 weeks	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.
Secondary	Time to Tumor Progression (TTP)	Time from study enrollment to radiographically determined tumor progression or recurrence, assessed up to 5 years	The distribution of TTP will be analyzed separately using product limit (PL) estimate.
Secondary	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	The distribution of TTF will be analyzed separately using PL estimate.
Secondary	Time to Death (TTD)	Time from study enrollment to death from any cause, assessed up to 5 years	The distribution of TTD will be analyzed separately using PL estimate.
Secondary	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	Rate of individual toxicity including that of symptomatic ITH will be summarized in each course of treatment using standard descriptive statistical methods.
Secondary	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	Cilengitide plasma concentration-time data are fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. For each patient, samples collected at different time points are used to derive one Vc value per patient.
Secondary	Pharmacokinetic Parameter of Cilengitide in Plasma: Elimination Rate Constant (Ke)	At baseline and 1, 3, and 6 hours after the first dose of cilengitide	Cilengitide plasma concentration-time data are fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. For each patient, samples collected at different time points are used to derive one Ke value per patient.
Secondary	Pharmacokinetic Parameter of Cilengitide in Plasma: Half-life (t1/2)	At baseline and 1, 3, and 6 hours after the first dose of cilengitide	Cilengitide plasma concentration-time data are fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. For each patient, samples collected at different time points are used to derive one t1/2 value per patient.
Secondary	Pharmacokinetic Parameter of Cilengitide in Plasma: Systemic Clearance (Cl)	At baseline and 1, 3, and 6 hours after the first dose of cilengitide	Cilengitide plasma concentration-time data are fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. For each patient, samples collected at different time points are used to derive one Cl value per patient.
Secondary	Pharmacogenetic Polymorphism in Drug Transporter Gene ABCB1 and Relate to Cilengitide Disposition as Measured by AUC	At baseline	Cilengitide systemic exposure as measured by AUC is used in this genotype-phenotype analysis. The ABCB1 (P-glycoprotein; P-gp) Exon 26 genotype is coded as 0/1/2 based on the number of T alleles.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response to Cilengitide	Up to 16 weeks	Six patients are considered inevaluable for objective response (including one ineligible patient) and excluded from analysis.	participants	NUMBER
SECONDARY	Time to Tumor Progression (TTP)	Time from study enrollment to radiographically determined tumor progression or recurrence, assessed up to 5 years	29 eligible patients are included in the analysis.	Days	MEDIAN
SECONDARY	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	Twenty-nine eligible patients are included in the analysis.	Days	MEDIAN
SECONDARY	Time to Death (TTD)	Time from study enrollment to death from any cause, assessed up to 5 years	Twenty-nine eligible patients are included in the analysis.	Days	MEDIAN
SECONDARY	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	Twenty-nine eligible patients are included in the analysis. One patient was excluded due to ineligibility.	percent of pts with symptomatic ITH	NUMBER
SECONDARY	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	All 18 patients consenting for pharmacokinetic study are included in this analysis.	L/m^2	MEDIAN
SECONDARY	Pharmacokinetic Parameter of Cilengitide in Plasma: Elimination Rate Constant (Ke)	At baseline and 1, 3, and 6 hours after the first dose of cilengitide	All 18 patients consenting for pharmacokinetic study are included in this analysis.	hr^(-1)	MEDIAN
SECONDARY	Pharmacokinetic Parameter of Cilengitide in Plasma: Half-life (t1/2)	At baseline and 1, 3, and 6 hours after the first dose of cilengitide	All 18 patients consenting for pharmacokinetic study are included in this analysis.	hours	MEDIAN
SECONDARY	Pharmacokinetic Parameter of Cilengitide in Plasma: Systemic Clearance (Cl)	At baseline and 1, 3, and 6 hours after the first dose of cilengitide	All 18 patients consenting for pharmacokinetic study are included in this analysis.	L/hr/m^2	MEDIAN
SECONDARY	Pharmacogenetic Polymorphism in Drug Transporter Gene ABCB1 and Relate to Cilengitide Disposition as Measured by AUC	At baseline	The analysis includes 12 eligible patients with both AUC data and ABCB1 Exon 26 data available.	Spearman's correlation	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Objective Response to Cilengitide	Treatment (Cilengitide)	With Objective Response	1		participants
Objective Response to Cilengitide	Treatment (Cilengitide)	Without Objective Response	23		participants
Time to Tumor Progression (TTP)	Treatment (Cilengitide)		28	Inter-Quartile Range 25 to 41	Days
Time to Treatment Failure (TTF)	Treatment (Cilengitide)		28	Inter-Quartile Range 25 to 41	Days
Time to Death (TTD)	Treatment (Cilengitide)		172	Inter-Quartile Range 99 to 226	Days
Rate of Toxicity, Especially That of Symptomatic Intratumoral Hemorrhage (ITH) Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Treatment (Cilengitide)		6.9		percent of pts with symptomatic ITH
Pharmacokinetic Parameter of Cilengitide in Plasma: Volume of Central Compartment (Vc)	Treatment (Cilengitide)		6.20	Full Range 3.34 to 10.72	L/m^2
Pharmacokinetic Parameter of Cilengitide in Plasma: Elimination Rate Constant (Ke)	Treatment (Cilengitide)		0.58	Full Range 0.36 to 1.00	hr^(-1)
Pharmacokinetic Parameter of Cilengitide in Plasma: Half-life (t1/2)	Treatment (Cilengitide)		1.26	Full Range 0.69 to 1.90	hours
Pharmacokinetic Parameter of Cilengitide in Plasma: Systemic Clearance (Cl)	Treatment (Cilengitide)		3.84	Full Range 2.47 to 5.75	L/hr/m^2

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment (Cilengitide)	30
Overall Study	COMPLETED	Treatment (Cilengitide)	0
Overall Study	NOT COMPLETED	Treatment (Cilengitide)	30

Source ClinicalTrials.gov

Adverse events26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Allergic reaction	Immune system disorders	Treatment (Cilengitide)	1	29
other	Constipation	Gastrointestinal disorders	Treatment (Cilengitide)	1	29
other	Depressed level of consciousness	Nervous system disorders	Treatment (Cilengitide)	1	29
other	Facial nerve disorder	Nervous system disorders	Treatment (Cilengitide)	1	29
other	Fatigue	General disorders	Treatment (Cilengitide)	1	29
other	Headache	Nervous system disorders	Treatment (Cilengitide)	2	29
other	Hypophosphatemia	Metabolism and nutrition disorders	Treatment (Cilengitide)	1	29
other	Lymphocyte count decreased	Investigations	Treatment (Cilengitide)	2	29
other	Muscle weakness left-sided	Musculoskeletal and connective tissue disorders	Treatment (Cilengitide)	1	29
other	Nervous system disorders - Other, specify	Nervous system disorders	Treatment (Cilengitide)	1	29

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment (Cilengitide)
Total, other adverse events	Treatment (Cilengitide)	8	29
Total, serious adverse events	Treatment (Cilengitide)	8	29

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00679354

GET https://conductscience.org/api/trials/v1/NCT00679354/events?page=2

API reference For AI assistants