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| ID | Type | Description | Link |
|---|---|---|---|
| ABT510 | Other Identifier | Drug name from FDA |
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To determine the maximum tolerated dose of ABT 510 when administered concurrent with radiation therapy for patients with newly diagnosed glioblastoma multiforme.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT 510 | Experimental | The only arm will receive the ABT 510 following standard therapy with radiation and temozolomide chemotherapy concurrent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT 510 | Drug | ABT 510 (TSP-1 mimetic peptide) is a parenterally available nonapeptide analog of the heptapeptide and is a potent inhibitor of angiogenesis. ABT 510 competes with TSP-1 for binding to endothelial cells, but the exact mechanism of anti-angiogenesis is unknown. ABT 510 is administered by SQ injection. The starting dose of ABT 510 will be 20mg once daily (QD) SQ. Doses will be escalated by approximately 50% increments in consecutive cohorts of 3-6 patients until maximum tolerated dose is achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| All patients enrolled in this study will be statistically characterized for baseline and disease characteristics using descriptive statistics for continuous measures. | The primary outcome for the study was safety and to define the MTD (max tolerated dose). Also, survival was to be measured but the study was not powered to statistically have significance for that measure. | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or breast feeding.
Prior therapy for the brain tumor (except surgery)
Prior treatment with antineoplastic agents.
Exclude sexually active males and females unwilling to practice contraception during the study.
Serious concurrent infections.
Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias ) or myocardial infarction within the last 12 months.
Patients who have had prior cytotoxic chemotherapy prior to radiation therapy.
Patients with other serious uncontrolled co-morbid diseases that the investigator feels may comprise the study findings.
Patients must be able to learn to self -administer or have another person administer subcutaneous(SQ) injections.
Patients who have received any other investigational agents within the 28 days prior to Day 1 of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Louis B Nabors, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C500617 | NAc-Sar-Gly-Val-(d-allo-Ile)-Thr-Nva-Ile-Arg-ProNEt |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |