Trial · NCT00085254

Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

NCT00085254, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-02-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme. Trials, record NCT00085254. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00085254

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Trial

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

Title: Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT number: NCT00085254
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 112 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
Interventions: cilengitide, temozolomide, radiation therapy, laboratory biomarker analysis, pharmacological study
First posted: 2004-06-11
Last updated: 2016-02-25
Results first posted: 2016-02-25
Limitations and caveats: Study is safety run-in / phase 2 study. Pre-defined doses in safety run-in, 500, 1000 \& 2000mg. Safety run-in is under an assumption of low probability of DLT with these dosages. NO actual MTD was defined in the safety run in, all doses were safe.

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Dose Limiting Toxicities of EMD + RT and TMZ	10 weeks	pts will be evaluated from first dose through end of initiation cycle. (6 weeks of RT+TMZ +EMD and 4 weeks of EMD alone) to review dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting. Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)
Primary	Maximum Tolerated or Tolerable Dose (MTD) - 3 Pre-defined Doses	10 weeks	pts will be evaluated from first dose through end of initiation cycle. (6 weeks of RT+TMZ +EMD and 4 weeks of EMD alone) to review any dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (safety run-in) DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting. cohorts at these 3 defined doses: 500mg, 1000mg and 2000mg MTD defined as: dose producing DLT in 2 out of 6 patients or dose level below the dose which produced DLT in \>/= 2 out of 3 patients, or in \>/= 3 out of 6 patients If no MTD (maximum tolerable dose) was defined through 3 steps of dose escalation, phase 2 will proceed with a randomized treatment allocation of the two pre-specified dosage arms: low dose; 500mg and high dose; 2000mg
Primary	Overall Survival (Phase II)	up to 36 months	The overall survival is calculated from time of histological diagnosis to death occurance - median based on all 112 patients, all dose levels
Secondary	Overall Survival Based on Dose Level - Phase 2	Up to 3 years	survival calculated from date of initial histologic diagnosis and occurence of death. Pts at 500mg dose compared against Pts treated at 2000mg dose. Calculated using median
Secondary	Frequency of Hematologic and Nonhematologic Adverse Events	Up to 1 year	The proportion of patients with grade 3 and grade 4 hematologic and non hematologic adverse events per CTCAE 4.0

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Dose Limiting Toxicities of EMD + RT and TMZ	10 weeks	at least 3 pts per cohort will be used to review DLT rate for dose escalation in stepwise fashion. we will enroll 6 pts to ensure that 3 pts are evaluable due to high drop out rate.	participants	NUMBER
PRIMARY	Maximum Tolerated or Tolerable Dose (MTD) - 3 Pre-defined Doses	10 weeks	at least 3 pts per cohort will be used to review MTD rate for dose escalation in stepwise fashion of 3 defined doses: 500, 1000 and 2000mg. We will enroll 6 pts to ensure that 3 pts are evaluable due to high drop out rate.	mg	NUMBER
SECONDARY	Overall Survival Based on Dose Level - Phase 2	Up to 3 years	Phase 2 subjects only - does not include the 18 subjects from the safety run-in portion of study	months	MEDIAN
SECONDARY	Frequency of Hematologic and Nonhematologic Adverse Events	Up to 1 year		Number of grade 3 or 4 events	NUMBER
PRIMARY	Overall Survival (Phase II)	up to 36 months		months	MEDIAN

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Spread	Units
Dose Limiting Toxicities of EMD + RT and TMZ	Arm 1 500mg (Safety Run In)	0		participants
Dose Limiting Toxicities of EMD + RT and TMZ	ARM 2 1000mg (Safety run-in)	0		participants
Dose Limiting Toxicities of EMD + RT and TMZ	Arm 3 2000mg (Safety Run-In)	0		participants
Maximum Tolerated or Tolerable Dose (MTD) - 3 Pre-defined Doses	Arm 1 - Safety Run In	NA		mg
Overall Survival Based on Dose Level - Phase 2	Arm 1 - Phase 2 (Treatment 1)	17.4	95% Confidence Interval 13.3 to 21.6	months
Overall Survival Based on Dose Level - Phase 2	Arm 2 - Phase 2 (Treatment 2)	20.8	95% Confidence Interval 7 to 24	months
Frequency of Hematologic and Nonhematologic Adverse Events	Arm 1- Phase 2 (500mg)	48		Number of grade 3 or 4 events
Frequency of Hematologic and Nonhematologic Adverse Events	Arm 2 - Phase 2 (2000mg)	35		Number of grade 3 or 4 events
Overall Survival (Phase II)	Arm 4 (Overall Study)	19.7	95% Confidence Interval 16.6 to 21.9	months

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1 (Safety Run In)	18
Overall Study	STARTED	Arm 2 - Phase II (Treatment 1)	46
Overall Study	STARTED	Arm 3 - Phase II (Treatment 2)	48
Overall Study	COMPLETED	Arm 1 (Safety Run In)	18
Overall Study	COMPLETED	Arm 2 - Phase II (Treatment 1)	46
Overall Study	COMPLETED	Arm 3 - Phase II (Treatment 2)	48
Overall Study	NOT COMPLETED	Arm 1 (Safety Run In)	0
Overall Study	NOT COMPLETED	Arm 2 - Phase II (Treatment 1)	0
Overall Study	NOT COMPLETED	Arm 3 - Phase II (Treatment 2)	0

Source ClinicalTrials.gov

Adverse events66

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 increased	Investigations	Dose 500	0	52	0
other	Alanine aminotransferase increased	Investigations	Dose 1000	0	6	0
other	Alanine aminotransferase increased	Investigations	Dose 2000	2	54	2
other	Aspartate aminotransferase increased	Investigations	Dose 500	1	52	1
other	Aspartate aminotransferase increased	Investigations	Dose 1000	0	6	0
other	Aspartate aminotransferase increased	Investigations	Dose 2000	1	54	1
other	anorexia	Metabolism and nutrition disorders	Dose 500	1	52	1
other	anorexia	Metabolism and nutrition disorders	Dose 1000	0	6	0
other	anorexia	Metabolism and nutrition disorders	Dose 2000	0	54	0
other	dehydration	Metabolism and nutrition disorders	Dose 500	0	52	0

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dose 500
Total, all-cause mortality	Dose 1000
Total, all-cause mortality	Dose 2000
Total, other adverse events	Dose 500	11	52
Total, other adverse events	Dose 1000	0	6
Total, other adverse events	Dose 2000	14	54
Total, serious adverse events	Dose 500	0	52
Total, serious adverse events	Dose 1000	0	6
Total, serious adverse events	Dose 2000	1	54

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22517399	RESULT

Source PubMed

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
U01CA062475	NABTT-Consortium Therapeutic Studies of CNS Malignancies	GROSSMAN, STUART A	JOHNS HOPKINS UNIVERSITY	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.

GET https://conductscience.org/api/trials/v1/NCT00085254

GET https://conductscience.org/api/trials/v1/NCT00085254/events?page=2

API reference For AI assistants