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| ID | Type | Description | Link |
|---|---|---|---|
| NABTT 0306 | |||
| CDR0000368451 | |||
| U01CA062475 | U.S. NIH Grant/Contract | View source |
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Cilengitide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving cilengitide together with temozolomide and radiation therapy may kill more tumor cells. This randomized phase I/II trial is studying the side effects and best dose of cilengitide when given together with temozolomide and radiation therapy and to compare how well they work in treating patients with newly diagnosed glioblastoma multiforme
PRIMARY OBJECTIVES:
I. To assess the safety profile of EMD 121974 (cilengitide) when administered as a one-hour infusion twice a week concurrently with concomitant and adjuvant temozolomide with radiation therapy for newly diagnosed glioblastoma multiforme. (Safety Run-In)
II. To estimate overall survival in newly diagnosed patients with glioblastoma multiforme treated with EMD 121974 concurrently with concomitant and adjuvant temozolomide with radiation therapy. (Phase II)
SECONDARY OBJECTIVES:
I. To estimate and compare overall survival between a low dose treatment group and a high dose treatment group in newly diagnosed patients with glioblastoma multiforme treated with EMD 121974 concurrently with concomitant and adjuvant temozolomide with radiation therapy. (Phase II)
II. To determine the toxicity of EMD 121974 (cilengitide) when it is administered in conjunction with concomitant and adjuvant temozolomide with radiation therapy in patients with newly diagnosed glioblastoma multiforme. (Phase II)
III. To evaluate the molecular profile of individual patients and correlate molecular expression profiles with clinical outcomes. (Phase II)
IV. To characterize tumor blood volume, tumor blood flow, and permeability ratios using perfusion MR in newly diagnosed glioblastoma multiforme and follow these parameters during treatment with EMD 121974 (cilengitide). (Phase II)
OUTLINE: This is an open-label, multicenter, safety run-in study of cilengitide followed by a randomized phase II study.
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.
Cohorts of 3-6 patients receive escalating doses of cilengitide (3 Pre-defined study dose levels are defined as: 500, 1000 and 2000mg). The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity. If no MTD (maximum tolerable dose) is defined through three steps of the dose escalation process, we will pursue the phase II safety/efficacy study with randomized treatment allocation. Patients will be randomized into one of two pre-specified treatment dosage arms, 500mg group or 2000mg group.
PHASE II:
Patients are stratified according to age (50 and under vs over 50), Karnofsky performance score (60%-80% vs 90%-100%), and tumor status (measurable vs nonmeasurable). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive radiotherapy and temozolomide as in safety run-in initiation course and cilengitide at the lower dose as in safety run-in initiation and maintenance courses.
ARM II: Patients receive radiotherapy and temozolomide as in safety run-in initiation course and cilengitide at the higher dose as in safety run-in initiation and maintenance courses.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 9-112 patients (9-18 for safety run-in and 94 [47 per treatment arm] for phase II) will be accrued for this study within 1.5-37 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Safety Run In) | Experimental | 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 |
|
| Phase II (Arm1-500mg) | Experimental | 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 |
|
| Phase II (Arm 2 -2000mg) | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cilengitide | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities of EMD + RT and TMZ | 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) | 10 weeks |
| Maximum Tolerated or Tolerable Dose (MTD) - 3 Pre-defined Doses | 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 | 10 weeks |
| Overall Survival (Phase II) | The overall survival is calculated from time of histological diagnosis to death occurance - median based on all 112 patients, all dose levels | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Based on Dose Level - Phase 2 | 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 | Up to 3 years |
| Frequency of Hematologic and Nonhematologic Adverse Events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis Nabors, MD | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22517399 | Result | Nabors LB, Mikkelsen T, Hegi ME, Ye X, Batchelor T, Lesser G, Peereboom D, Rosenfeld MR, Olsen J, Brem S, Fisher JD, Grossman SA; New Approaches to Brain Tumor Therapy (NABTT) Central Nervous System Consortium. A safety run-in and randomized phase 2 study of cilengitide combined with chemoradiation for newly diagnosed glioblastoma (NABTT 0306). Cancer. 2012 Nov 15;118(22):5601-7. doi: 10.1002/cncr.27585. Epub 2012 Apr 19. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| temozolomide | Drug | Given orally |
|
|
| radiation therapy | Radiation | Undergo radiotherapy |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| pharmacological study | Other | Correlative studies |
|
|
The proportion of patients with grade 3 and grade 4 hematologic and non hematologic adverse events per CTCAE 4.0 |
| Up to 1 year |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| FG001 | 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 |
| FG002 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
pt had undergone previous surgery and had histological diagnosis of glioblastoma. All pt 18 years or older and KPS greater or equal to 60%
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Arm 2 - Phase 2 (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 (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 |
| BG002 | Arm 3 - Phase 2 (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 (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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Karnofsky Performance Status | 100 - Normal; no complaints; no evidence of disease 90 - Able to carry on normal activity; minor signs or symptoms of disease 80 - Normal activity with effort; some signs or symptoms of disease 70 - Cares for self; unable to carry on normal activity or to do active work 60 - Requires occasional assistance, but is able to care for most of his personal needs | Number | participants |
| |||||||||||||||
| Surgical Proceedure | Number | participants |
| ||||||||||||||||
| Corticosteroid Therapy | Number | participants |
| ||||||||||||||||
| MGMT Statis | 0-6-methylguanine-DNA methyltransferase | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dose Limiting Toxicities of EMD + RT and TMZ | 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) | 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. | Posted | Number | participants | 10 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Maximum Tolerated or Tolerable Dose (MTD) - 3 Pre-defined Doses | 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 | 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. | Posted | Number | mg | 10 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Based on Dose Level - Phase 2 | 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 | Phase 2 subjects only - does not include the 18 subjects from the safety run-in portion of study | Posted | Median | 95% Confidence Interval | months | Up to 3 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Frequency of Hematologic and Nonhematologic Adverse Events | The proportion of patients with grade 3 and grade 4 hematologic and non hematologic adverse events per CTCAE 4.0 | Posted | Number | Number of grade 3 or 4 events | Up to 1 year |
| |||||||||||||||||||||||||||||||||||
| Primary | Overall Survival (Phase II) | The overall survival is calculated from time of histological diagnosis to death occurance - median based on all 112 patients, all dose levels | Posted | Median | 95% Confidence Interval | months | up to 36 months |
|
|
From first dose of treatment in initiation phase until patient progresses on treatment, last dose, off treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose 500 | 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 | 0 | 52 | 11 | 52 | ||
| EG001 | Dose 1000 | 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 | 0 | 6 | 0 | 6 | ||
| EG002 | Dose 2000 | 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 | 1 | 54 | 14 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extraocular muscle paresis | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema Face | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| somnolence | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment | thrombosis |
|
| vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| blood -other | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Louis Burt Nabors, MD | Adult Brain Tumor Consortium (ABTC) | 205-934-1432 | bnabors@uab.edu |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C422910 | Cilengitide |
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
Not provided
Not provided
| Male |
|
| 90 |
|
| 80 |
|
| 70 |
|
| 60 |
|
| craniotomy |
|
| other |
|
| No |
|
| missing data |
|
| unmethylated |
|
| unknown |
|
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|
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|
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