Trial · NCT00112866

Cilengitide in Treating Patients Who Are Undergoing Surgery for Recurrent or Progressive Glioblastoma Multiforme

NCT00112866, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2017-06-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cilengitide in Treating Patients Who Are Undergoing Surgery for Recurrent or Progressive Glioblastoma Multiforme. Trials, record NCT00112866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00112866

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Trial

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

Title: Cilengitide in Treating Patients Who Are Undergoing Surgery for Recurrent or Progressive Glioblastoma Multiforme
NCT number: NCT00112866
Status: Terminated
Phases: Phase 2
Enrollment: 30 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
Interventions: cilengitide, therapeutic conventional surgery, pharmacological study, laboratory biomarker analysis
First posted: 2005-06-03
Last updated: 2017-06-14
Results first posted: 2017-06-14
Limitations and caveats: Study closed early due to slow accrual. Molecular analyses evaluating alterations were planned for the study, unfortunately, majority of tumor samples were too small to do analysis and also there were unforeseen freezer issues.

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	6m-Progression-free Survival	6 months	progression within 6 months (26 weeks) of treatment
Secondary	Changes in avb3 Integrin Expression on Tumor Cells and Endothelial Cells	Baseline and time of surgery	Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.
Secondary	Changes in Vitronectin Expression	Baseline and time of surgery	Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.
Secondary	Changes in Tumor Cell Apoptosis	Baseline and time of surgery	Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.
Secondary	Changes in Tumor Cell Proliferation	Baseline and time of surgery	Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.
Secondary	Changes in Endothelial Cell Apoptosis	Baseline and up to 4 years	Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.
Secondary	Plasma Concentration of EMD 121974	24 hour post concentration	24 hour post dose concentration plasma, at time of resection
Secondary	Tumor Tissue Concentrations	at time of surgery	a section of tumor of approximately 500mg will be snap frozen (immediately prepared and frozen) once removed from brain for analysis of the drug concentration in contrast -enhancing tumor.
Other	Overall Progression Free Survival	1 year	Kaplan-meier curve

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	6m-Progression-free Survival	6 months	6months progression free survival based on the post surgical treatment. All patients received 2000mg post surgery. The pre-surgery dose was used for correlative purposes only. All patients received surgery and the doses pre-surgery have no relation to the primary objective.	percent	NUMBER
SECONDARY	Changes in avb3 Integrin Expression on Tumor Cells and Endothelial Cells	Baseline and time of surgery	Molecular analyses evaluating alterations after cilengitide treatments were planned as a component of this clinical trial, unfortunately, the majority of tumor samples were too small to do both measures of drug and molecular analysis or the sample was inadequate for both after removal of areas of necrosis and gliosis
SECONDARY	Changes in Vitronectin Expression	Baseline and time of surgery	Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis
SECONDARY	Changes in Tumor Cell Apoptosis	Baseline and time of surgery	Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis
SECONDARY	Changes in Tumor Cell Proliferation	Baseline and time of surgery	Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis
SECONDARY	Changes in Endothelial Cell Apoptosis	Baseline and up to 4 years	Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis
SECONDARY	Plasma Concentration of EMD 121974	24 hour post concentration	6 of 8 and 7 of 11 plasma samples at the 500mg and 2000mg dose level respectively, were below the lower level of quantitation (LLOQ) Of the 15 samples in the low dose group only 8 were evaluable and 11 of the 15 for the high dose group. Samples were either damaged or too small for analysis.	ng/ml	MEAN
SECONDARY	Tumor Tissue Concentrations	at time of surgery	8 500mg dose tissue samples and 10 2000mg dose tissue samples were either too small or had large areas of necrosis and gliosis to do analysis/evaluation	ng/g	MEAN
OTHER_PRE_SPECIFIED	Overall Progression Free Survival	1 year	Overall survival based on the post surgical treatment. All patients received 2000mg post surgery. The pre-surgery dose was used for correlative purposes only. All patients received surgery and the doses pre-surgery have no relation to the this objective.	weeks	MEDIAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
6m-Progression-free Survival	Post-Operative Treatment 2000mg	12		percent
Plasma Concentration of EMD 121974	Group I (Low-dose Cilengitide) 500mg	333	Standard Deviation 16.97	ng/ml
Plasma Concentration of EMD 121974	Group II High-dose Cilengitide) 2000mg	386	Standard Deviation 184	ng/ml
Tumor Tissue Concentrations	Group I (Low-dose Cilengitide) 500mg	919	Standard Deviation 1235	ng/g
Tumor Tissue Concentrations	Group II (High-dose Cilengitide) 2000mg	1413	Standard Deviation 1335	ng/g
Overall Progression Free Survival	Post-Operative Treatment 2000mg	8	95% Confidence Interval 4 to 16	weeks

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Low Dose 500mg Group 1	15
Overall Study	STARTED	High Dose 2000mg Group 2	15
Overall Study	COMPLETED	Low Dose 500mg Group 1	13
Overall Study	COMPLETED	High Dose 2000mg Group 2	13
Overall Study	NOT COMPLETED	Low Dose 500mg Group 1	2
Overall Study	NOT COMPLETED	High Dose 2000mg Group 2	2

Source ClinicalTrials.gov

Adverse events14

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	Events
other	Alanine aminotransferase	Investigations	Post-Operative 2000mg	2	26	2
other	anorexia	Metabolism and nutrition disorders	Post-Operative 2000mg	2	26	2
other	bruising	Injury, poisoning and procedural complications	Post-Operative 2000mg	2	26	2
other	diarrhea	Gastrointestinal disorders	Post-Operative 2000mg	2	26	2
other	fatigue	General disorders	Post-Operative 2000mg	8	26	8
other	hemoglobin	Investigations	Post-Operative 2000mg	8	26	8
other	hyperglycemia	Metabolism and nutrition disorders	Post-Operative 2000mg	3	26	3
other	hyponatremia	Metabolism and nutrition disorders	Post-Operative 2000mg	2	26	2
other	hypoalbuminemia	Metabolism and nutrition disorders	Post-Operative 2000mg	3	26	3
other	leukocytes	Blood and lymphatic system disorders	Post-Operative 2000mg	10	26	10

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Post-Operative 2000mg
Total, other adverse events	Post-Operative 2000mg	26	26
Total, serious adverse events	Post-Operative 2000mg	0	26

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
U01CA062399	NABTC Central Operation Grant (UCSF Project Leader)	PRADOS, MICHAEL D	UNIVERSITY OF CALIFORNIA, SAN FRANCISCO	NATIONAL CANCER INSTITUTE	1994 to 2008

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.

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