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

NCT ID: NCT00584883

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2008-07-31

Brief 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).

Conditions

Brain Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABT 510

The only arm will receive the ABT 510 following standard therapy with radiation and temozolomide chemotherapy concurrent.

Group Type: EXPERIMENTAL

ABT 510

Intervention Type: 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.

Interventions

ABT 510

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.

Intervention Type: DRUG

Eligibility Criteria

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.

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• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Louis Burt Nabors, MD

Professor, Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis B Nabors, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

ABT510

Identifier Type: OTHER

Identifier Source: secondary_id

UAB 0327

Identifier Type: -

Identifier Source: org_study_id