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A Phase I Study of ABT 510 for Newly Diagnosed Glioblastoma Multiforme | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Phase I Study of ABT 510 for Newly Diagnosed Glioblastoma Multiforme

A Phase I Study of ABT 510 and Concurrent Temozolomide and Radiotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme

NCT00584883•University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

To determine the maximum tolerated dose of ABT 510 when administered concurrent with radiation therapy for patients with newly diagnosed glioblastoma multiforme.

Detailed Description

1. To describe the toxicity associated with this regimen in adult patients with newly diagnosed glioblastoma multiforme. 2. To determine the duration of disease free survival and overall survival associated with this therapy. 3. Evaluate thrombospondin 1 (TSP-1) and 2 (TSP-2) in tumor vs. corresponding normal tissue using quantitative real time Polymerase Chain Reaction (Q-RT-PCR). 4. Determine the effect of ABT 510 on tumor permeability and tumor blood volume as measured by non-invasive Magnetic Resonance Imaging (MRI).

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must be 19 years of age or older.
•2. Patients must have histologically proven newly diagnosed glioblastoma multiforme.
•3. Patients must have fully recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen for 5 days prior to entry.
•4. Patients must have a Karnofsky performance status \> 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
•5. Patients must have adequate hematologic, renal and liver function (i.e. Absolute neutrophil count \> 1500/mm3, Platelets \> 100,000/mm3, creatinine 1.5 mg/dl .
•6. Women of childbearing potential must have a negative pregnancy test.
•7. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. The effect of the investigational drugs on the developing human fetus is not known, but these drugs are likely to be harmful to the developing fetus or nursing infant. Women of child-bearing potential must agree to use adequate contraception (either surgical sterilization; approved hormonal contraceptives such as birth control pills Depo-Provera, or Lupron Depot; barrier methods such as condom or diaphragm along with spermicide; or an Intrauterine device (IUD)). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and study PI immediately.
•8. The patient is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.
•9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

•1. Pregnant or breast feeding.
•2. Prior therapy for the brain tumor (except surgery)
•3. Prior treatment with antineoplastic agents.
•4. Exclude sexually active males and females unwilling to practice contraception during the study.
•5. Serious concurrent infections.
•6. 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.
•7. Patients who have had prior cytotoxic chemotherapy prior to radiation therapy.
•8. Patients with other serious uncontrolled co-morbid diseases that the investigator feels may comprise the study findings.
•9. Patients must be able to learn to self -administer or have another person administer subcutaneous(SQ) injections.
•10. Patients who have received any other investigational agents within the 28 days prior to Day 1 of the study.
+1 more criteria

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Key Dates

Start Date

August 1, 2003

Primary Completion Date

July 1, 2008

Completion Date

July 1, 2008

Last Updated

June 7, 2023

Enrollment

ACTUAL participants

Conditions

Brain Tumor

Interventions

ABT 510

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITINGNA

The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery (IPSIMANON)

NCT06962215

Brain Tumor Adult

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase I Study of ABT 510 for Newly Diagnosed Glioblastoma Multiforme

Inclusion Criteria

Exclusion Criteria

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