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

Primary Purpose

Brain Tumor

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ABT 510

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring Patients who have newly diagnosed brain tumors

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must be 19 years of age or older.
Patients must have histologically proven newly diagnosed glioblastoma multiforme.
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.
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).
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 .
Women of childbearing potential must have a negative pregnancy test.
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.
The patient is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.
Ability to understand and the willingness to sign a written informed consent document.

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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Sites / Locations

University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABT 510

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00584883

First Posted

December 26, 2007

Last Updated

June 6, 2023

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT00584883

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

To describe the toxicity associated with this regimen in adult patients with newly diagnosed glioblastoma multiforme. To determine the duration of disease free survival and overall survival associated with this therapy. 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). Determine the effect of ABT 510 on tumor permeability and tumor blood volume as measured by non-invasive Magnetic Resonance Imaging (MRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Tumor

Keywords

Patients who have newly diagnosed brain tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABT 510

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ABT 510

Intervention Description

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.

Primary Outcome Measure Information:

Title

All patients enrolled in this study will be statistically characterized for baseline and disease characteristics using descriptive statistics for continuous measures.

Description

Time Frame

up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be 19 years of age or older. Patients must have histologically proven newly diagnosed glioblastoma multiforme. 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. 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). 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 . Women of childbearing potential must have a negative pregnancy test. 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. The patient is able to self-administer or has a caregiver who can reliably administer subcutaneous injections. Ability to understand and the willingness to sign a written informed consent document. 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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis B Nabors, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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