Trial Outcomes & Findings for Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (NCT NCT00085254)

Last Updated: 2016-02-25

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

112 participants

Primary outcome timeframe

10 weeks

Results posted on

2016-02-25

Participant Flow

Study sponsored by CTEP and conducted by New Approaches to Brain Tumor Therapy (NABTT). Pts accrued between April 2005 and December 2007. Pts were accrued from 11 Cancer Centers nation wide, in an outpatient setting. All pts had undergone previous surgery and had diagnosis of glioblastoma

Participant milestones

Participant milestones
Measure	Arm 1 (Safety Run In) INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV 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. Doses of cilengitide: 500mg, 1000mg and 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies	Arm 2 - Phase II (Treatment 1) INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV (500mg) 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. cilengitide, Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies	Arm 3 - Phase II (Treatment 2) INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV (2000mg) 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. cilengitide,Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Overall Study STARTED	18	46	48
Overall Study COMPLETED	18	46	48
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 - Safety Run In n=18 Participants INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV 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. Doses of cilengitide: 500mg, 1000mg and 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies	Arm 2 - Phase 2 (Treatment 1) n=46 Participants INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV 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. Doses of cilengitide: 500mg, 1000mg and 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies	Arm 3 - Phase 2 (Treatment 2) n=48 Participants INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV 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. Doses of cilengitide: 500mg, 1000mg and 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies	Total n=112 Participants Total of all reporting groups
Age, Continuous	55.6 years n=5 Participants	56.3 years n=7 Participants	54.9 years n=5 Participants	55.5 years n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants	46 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	28 Participants n=7 Participants	29 Participants n=5 Participants	66 Participants n=4 Participants
Karnofsky Performance Status 100	4 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants	27 participants n=4 Participants
Karnofsky Performance Status 90	6 participants n=5 Participants	27 participants n=7 Participants	18 participants n=5 Participants	51 participants n=4 Participants
Karnofsky Performance Status 80	5 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants	15 participants n=4 Participants
Karnofsky Performance Status 70	3 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	15 participants n=4 Participants
Karnofsky Performance Status 60	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants
Surgical Proceedure biopsy	6 participants n=5 Participants	10 participants n=7 Participants	9 participants n=5 Participants	25 participants n=4 Participants
Surgical Proceedure craniotomy	12 participants n=5 Participants	35 participants n=7 Participants	39 participants n=5 Participants	86 participants n=4 Participants
Surgical Proceedure other	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Corticosteroid Therapy Yes	13 participants n=5 Participants	33 participants n=7 Participants	36 participants n=5 Participants	82 participants n=4 Participants
Corticosteroid Therapy No	4 participants n=5 Participants	13 participants n=7 Participants	11 participants n=5 Participants	28 participants n=4 Participants
Corticosteroid Therapy missing data	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
MGMT Statis methylated	3 participants n=5 Participants	11 participants n=7 Participants	7 participants n=5 Participants	21 participants n=4 Participants
MGMT Statis unmethylated	9 participants n=5 Participants	21 participants n=7 Participants	18 participants n=5 Participants	48 participants n=4 Participants
MGMT Statis unknown	6 participants n=5 Participants	14 participants n=7 Participants	23 participants n=5 Participants	43 participants n=4 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Arm 1 500mg (Safety Run In) n=3 Participants INITIATION COURSE: Patients receive cilengitide 500 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 500mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)	ARM 2 1000mg (Safety run-in) n=4 Participants INITIATION COURSE: Patients receive cilengitide 1000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 1000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)	Arm 3 2000mg (Safety Run-In) n=6 Participants INITIATION COURSE: Patients receive cilengitide 2000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)
Dose Limiting Toxicities of EMD + RT and TMZ	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: 10 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	Arm 1 500mg (Safety Run In) n=13 Participants INITIATION COURSE: Patients receive cilengitide 500 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 500mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)	ARM 2 1000mg (Safety run-in) INITIATION COURSE: Patients receive cilengitide 1000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 1000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)	Arm 3 2000mg (Safety Run-In) INITIATION COURSE: Patients receive cilengitide 2000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)
Maximum Tolerated or Tolerable Dose (MTD) - 3 Pre-defined Doses	NA mg MTD not achieved. No DLTs at any dose level that were sufficient to define a maximum tolerated dose. Toxicities were equally distributed across all 3 dose levels.	—	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Arm 1 500mg (Safety Run In) n=112 Participants INITIATION COURSE: Patients receive cilengitide 500 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 500mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)	ARM 2 1000mg (Safety run-in) INITIATION COURSE: Patients receive cilengitide 1000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 1000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)	Arm 3 2000mg (Safety Run-In) INITIATION COURSE: Patients receive cilengitide 2000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)
Overall Survival (Phase II)	19.7 months Interval 16.6 to 21.9	—	—

SECONDARY outcome

Timeframe: Up to 3 years

Population: Phase 2 subjects only - does not include the 18 subjects from the safety run-in portion of study

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

Outcome measures

Outcome measures
Measure	Arm 1 500mg (Safety Run In) n=46 Participants INITIATION COURSE: Patients receive cilengitide 500 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 500mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)	ARM 2 1000mg (Safety run-in) n=48 Participants INITIATION COURSE: Patients receive cilengitide 1000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 1000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)	Arm 3 2000mg (Safety Run-In) INITIATION COURSE: Patients receive cilengitide 2000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)
Overall Survival Based on Dose Level - Phase 2	17.4 months Interval 13.3 to 21.6	20.8 months Interval 7.0 to 24.0	—

SECONDARY outcome

Timeframe: Up to 1 year

The proportion of patients with grade 3 and grade 4 hematologic and non hematologic adverse events per CTCAE 4.0

Outcome measures

Outcome measures
Measure	Arm 1 500mg (Safety Run In) n=46 Participants INITIATION COURSE: Patients receive cilengitide 500 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 500mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)	ARM 2 1000mg (Safety run-in) n=48 Participants INITIATION COURSE: Patients receive cilengitide 1000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 1000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)	Arm 3 2000mg (Safety Run-In) INITIATION COURSE: Patients receive cilengitide 2000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. Doses of cilengitide: 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies 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)
Frequency of Hematologic and Nonhematologic Adverse Events	48 Number of grade 3 or 4 events	35 Number of grade 3 or 4 events	—

Adverse Events

Dose 500

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Dose 1000

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dose 2000

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose 500 n=52 participants at risk INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV 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. Doses of cilengitide: 500mg, 1000mg and 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies	Dose 1000 n=6 participants at risk INITIATION COURSE: Patients receive cilengitide (1000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV 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. Doses of cilengitide: 500mg, 1000mg and 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies	Dose 2000 n=54 participants at risk INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV 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. Doses of cilengitide: 500mg, 1000mg and 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Eye disorders Extraocular muscle paresis	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Gastrointestinal disorders Nausea	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Gastrointestinal disorders Vomiting	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
General disorders Edema Face	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
General disorders Death NOS	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Nervous system disorders Seizure	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.

Other adverse events

Additional Information

Louis Burt Nabors, MD

Adult Brain Tumor Consortium (ABTC)

Phone: 205-934-1432

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Dose 500 n=52 participants at risk INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV 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. Doses of cilengitide: 500mg, 1000mg and 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies	Dose 1000 n=6 participants at risk INITIATION COURSE: Patients receive cilengitide (1000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV 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. Doses of cilengitide: 500mg, 1000mg and 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies	Dose 2000 n=54 participants at risk INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV 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. Doses of cilengitide: 500mg, 1000mg and 2000mg Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study cilengitide: Given IV temozolomide: Given orally radiation therapy: Undergo radiotherapy laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Investigations Alanine aminotransferase increased	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	3.7% 2/54 • Number of events 2 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Investigations Aspartate aminotransferase increased	1.9% 1/52 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Metabolism and nutrition disorders anorexia	1.9% 1/52 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/54 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Metabolism and nutrition disorders dehydration	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
General disorders fatigue	5.8% 3/52 • Number of events 3 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Nervous system disorders headache	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	3.7% 2/54 • Number of events 2 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Metabolism and nutrition disorders hyponatremia	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Metabolism and nutrition disorders hypophosphatemia	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Musculoskeletal and connective tissue disorders muscle weakness	1.9% 1/52 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/54 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Gastrointestinal disorders nausea	1.9% 1/52 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/54 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Skin and subcutaneous tissue disorders rash	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Nervous system disorders somnolence	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Vascular disorders Thromboembolic event	5.8% 3/52 • Number of events 3 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/54 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Gastrointestinal disorders vomiting	1.9% 1/52 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Blood and lymphatic system disorders blood -other	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/52 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	0.00% 0/6 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.	1.9% 1/54 • Number of events 1 • From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.